(5) A Significant Difference in Frequencies of Adverse Events Associated with Laparoscopic Staplers* :
The numbers of reported adverse events in the FDA Manufacturer and User Facility Device Experience
(MAUDE) Database associated with the laparoscopic staplers of the two major manufacturers differ substantially**.
Note 1 : The significant difference is not easily explainable based on the difference in the market shares of the
laparoscopic staplers of the two manufacturers alone (see the graph below).
Note 2 : The difference in the frequencies of adverse events, taken as a whole, may point to an important difference(s)
in the performance characteristics of the laparoscopic staplers of the two manufacturers despite the fact that both are
deemed safe and effective, and cleared by FDA through the 510(k) process.
* See Section "Path Forward | The First Step".
** Selected parts of the representative brand names of each manufacturer's laparoscopic stapler products (manual & powered) were used in querying the MAUDE data base.
(6) A Higher Rate of Incidence of Stapler Overloading & Consequential Adverse Events* :
The probability of inadvertent stapler overloading due to mismatch between the selected staple type and tissue is
inevitably higher for a stapling system with fewer number of staple type selections.
Note 1 : Surgeons essentially randomly selects a staple type for tissue based on educated guess heavily reliant on past
experiences but with little or no information on its mechanical properties.
Note 2 : Probabilistically, the likelihood of mismatch between staple type and tissue has to be higher when the
surgeons are given a smaller pool of staple types to select from.
Note 3 : This analysis may partly but not entirely explain the observation described in paragraph (5) above.
Note 4 : The current FDA 510(k) regulation for staplers for internal use does not include special controls for screening
surgical stapling products against inherent propensity for causing instrument overloading or underloading.
* See Section "Path Forward | The Zeroth Step".
Path Forward | The Basics
INFORMATION RESERVED FOR FUTURE RELEASE including :
(1) Specifications for a surgical stapling system must include a rated load for safety and the thickness range of staples
must be determined taking the rated load into account.
(2) Dimension and shape of the legs of formed staples must be substantially consistent regardless of the height
of staples and without irregularities not scientifically supported.
Note 1 : A first (introduced in 2025) powered stapling product includes formed staples with offset legs with
accompanying claims of "evenly distributed pressure" not scientifically supported.
(3) The tissue contacting surface of staple cartridge must be flat without surface irregularities such as steps, bumps
or reinforcements not scientifically supported for the claimed benefits to surgical stapling nor properly investigated
for accompanying risks*.
(4) A powered surgical stapling system must not be allowed to operate entirely autonomously in clinically significant
step of stapling operation depriving the surgeon of ability to implement his/her clinical judgement, e.g., by a manual
override built in the stapler instrument.
Note 2 : A second (introduced in 2025) powered stapling product is configured to autonomously determine
the final height of formed staples during anastomosis operation**, a clear risk no one yet fully understands***.
* No publicly available information pertaining to the scientific bases and analyses of the risks associated with these significant modifications to the existing devices exists.
** According to the Instructions For Use
*** No scientific or plausibility argument in support of the operation involved in the autonomous determination of the final staple height is publicly available.
Path Forward | The Fundamentals
INFORMATION RESERVED FOR SELECTIVE RELEASE including :
(1) Mechanics of surgical stapling and tissue characterization with Tissue Intelligence devices
(2) Novel design principles of surgical stapling system (design inputs and outputs)*
(2') Scientific basis for adaptation of surgical stapling system for anatomy and physiology of an organ*
(3) Novel design principles of verification & validation tests for surgical stapling system*
(4) Novel design principles of static and organ-specific, dynamic performance tests for surgical stapling system*
(5) Novel principles of in situ, quantitative evaluation and grading of staple line quality post stapling operation*
(6) Novel principles of topical conditioning of staple line with a first specialty stapler** post stapling operation
* An element in support of inclusion by FDA in the Safer Technologies Program of Endoscape Surgical's surgical stapling system (see paragraph (1) in the preceding introductory Section)
** See Section "Path Forward | The First Step".
Path Forward | The Fundamentals, Kernel
INFORMATION RESERVED FOR SELECTIVE RELEASE
Path Forward | The Road Map
INFORMATION RESERVED FOR SELECTIVE RELEASE including :
(1) Strategies for development of organ-specific laparoscopic surgical stapling system
(2) Strategies for development of organ-specific surgical stapling system for open surgery
(3) Strategies for development of a vision driven, second specialty surgical stapling system* for robot assisted surgery
Note 1 : Free-form stapling enabled by autonomous vision-motion coordination capability of robot assisted surgery
platform
Note 2 : Free from drawbacks of hand-held stapling system including rigid constraints on staple line geometry and
tissue compression profile as well as large size and inherent structural deficiencies of end effector
* Information reserved for future release
DEVELOPMENT STRATEGIES FOR NOVEL SURGICAL STAPLING SYSTEM & REGULATORY FRAMEWORK
(1) Hand-held Stapling System :
Fast track collaboration with strategic partner(s) with currently marketed, hand-held surgical stapling products with
focus on The Path Forward | The Zeroth Step, Extended (Location: Santa Clara, CA)*
(2) Robotic Assisted Surgery Stapling System :
An exclusive, limited license of certain IPs to a manufacturer of currently marketed robotic assisted surgery systems
OPTIONALLY WITH an assistance in establishing regulatory and technological barriers against nascent competitors in
terms of surgical stapling tools &
OPTIONALLY WITH a micro-miniature force sensor technology IP for prevention of over-compression of tissue
applicable to stapling tools as well as common tissue manipulation tools of 5 mm profile diameter (direct contact
sensing, no force feedback)
(3) New Regulatory Framework :
Quickly establish a new baseline of 510k clearance framework** and a new product class tied to the new baseline
regulatory framework that is not accessible to the currently marketed surgical stapling products
* Further details to be made available to prospective partner(s)
** See Section "Path Forward | The Zeroth Step, Baseline".
INTELLECTUAL PROPERTIES
(1) Tissue Probe Devices :
U.S. Patents 10,682,139, 11,197,669, 11,278,283, 11,284,894, 11,357,506, 12,357,305
(2) Surgical Brace Devices* :
U.S. Patents 10,512,464, 11,147,555
(3) Force Sensor Technologies and Tissue Probe Devices :
. . . . .
(4) Staple Line Inspection/Evaluation Methods and Devices :
. . . . .
(5) Adaptation of Stapling System Based on Target Organ, Methods and Devices :
. . . . .
(6) Selection of Staple Type, Methods and Devices :
. . . . .
(7) Specialty Surgical Stapling Systems :
. . . . .
(8) Specialty Surgical Stapling System for Robotic Assisted Surgery System, Methods and Devices :
. . . . .
. . . . .
* See Section "Path Forward | The Zeroth Step, Baseline".
Path Forward | The Zeroth Step
OVERLOAD INDICATOR FOR PROTECTION AGAINST STAPLER OVERLOAD & INFORMED SELECTION OF STAPLE TYPE
(1) An organ-specific Overload Indicator assembly built in a legacy stapling system
or
(2) An organ-specific Overload Indicator technology implemented in a dedicated device
and/or
(3) An organ-specific Tissue Intelligence Device based on a proprietary force sensor technology (of higher and lower
precision than the Overload Indicator technology and the Tissue Probe technology, respectively)
EXPANDED SELECTION OF STAPLE TYPE*
A staple reload with staples of formed height of 3.0 mm and color code of light green
* See paragraph (6) in the introductory Section.
IN SITU EVALUATION OF STAPLE LINE QUALITY*
(1) Quick & quantitative survey of staple line post stapling operation for presence of critical deficiencies
(2) A simple Spot Checker device for stapled tissue derived from the Overload Indicator technology
* See Section "Path Forward | The Second Step".
Path Forward | The Zeroth Step, Baseline
LEGACY MANUAL LAPAROSCOPIC SURGICAL STAPLING SYSTEM WITH A NEW REGULATORY COMPLIANCE BASELINE
(1) A clone of currently marketed surgical stapler with a cartridge jaw for releasably receiving a staple cartridge
(2) A set of clone, flat-deck staple cartridges (formed height of staple) : blue (1.5 mm), gold (1.75 mm) & green (2.0 mm)
&
(1') A clone of currently marketed surgical stapler handle configured to releasably receive a clone staple reload with
integrated, flat-deck staple cartridge
(2') A set of clone staple reloads (formed height of staple) : blue (1.5 mm), gold (1.75 mm) & green (2.0 mm with profile
diameter of 15 mm)
(3) An enhanced regulatory compliance framework (a future baseline for 510k clearance framework for all surgical
stapling system products, both hand-held & robotic assisted)
WITH pre-/post-firing, adjunct support(s) for improved safety and effectiveness and adapted for use with the clone of
legacy stapling system to include (compatible with flat-deck staple cartridge only):
(1) An organ specific, hand-held staple selection guide device based on the Overload Indicator technology
(2) An organ specific, hand-held staple line surveyor device for quantitative inspection & evaluation of staple line in
situ based on the Overload Indicator technology
(3) A hand-held surgical brace device for topical reinforcement of staple lines at geometric singularities, including
terminal ends and intersections, active bleeding and compromised staple line (An exemplary surgical brace device
deployed on a staple line is shown below for illustrative purpose only.) (U.S. Patents 10,512,464, 11,147,555)
SURGICAL STAPLING SYSTEM OF A CURRENTLY MARKETED ROBOTIC ASSISTED SURGERY SYSTEM
(1) A surgical stapling system with flat-deck staple cartridges cleared under the conventional regulatory framework
&
(1') A surgical stapling system with flat-deck staple cartridges with supplementary labeling pertaining to the enhanced
regulatory compliance framework & appropriately adapted adjunct support device(s) (see below)
WITH pre-/post-firing, adjunct support(s) for improved safety and effectiveness and adapted for use with the
currently marketed robotic assisted surgery system to include (initially hand-held version only with possible robotic
assisted version in the future, compatible with flat-deck staple cartridge only) :
(1) An organ specific, hand-held staple selection guide device based on the Overload Indicator technology
(2) An organ specific, hand-held staple line surveyor device for quantitative inspection & evaluation of staple line in
situ based on the Overload Indicator technology
(3) A hand-held surgical brace device for topical reinforcement of staple lines at geometric singularities, including
terminal ends and intersections, active bleeding, compromised staple line and tissue anomaly mainly due to
arbitrary variation of staple firing speed (U.S. Patents 10,512,464, 11,147,555)
ENHANCEMENTS OF THE CONVENTIONAL REGULATORY COMPLIANCE FRAMEWORK to include :
(1) A rated load for the surgical stapling system
(2) (Organ specific) thickness ranges for the staples determined, in part, taking the rated load into account
Path Forward | The Zeroth Step, Extended
SELF-CONTAINED LAPAROSCOPIC SURGICAL STAPLING SYSTEM
(1) A set of flat-deck (no steps or bumps or reinforcements) staple reload of color (staple formed height) : blue (1.5
mm), black (2.3 mm) & light green (3.0 mm)
(2) An organ-specific Overload Indicator device and/or Tissue Intelligence Device configured specifically for the staple
reload set & an optional Spot Checker device
(3) Optional adjunct tool kits for tuning the formed height of a staple or the level of tissue compression
(4) A legacy stapler handle capable of providing the full design compression upon initial closure of end effector
(5) To seek regulatory compliances through the regulatory framework in effect for the legacy surgical stapling system
with a key variation (see Section Path Forward | The Zeroth Step, Baseline)
Path Forward | The Bottom Line
POOR SCIENTIFIC FOUNDATION & RESULTANT PROBLEMS OF THE CURRENTLY MARKETED STAPLING PRODUCTS :
FALSE SENSE OF SAFETY | OVER-COMPRESSION OF TISSUE
(1) Tissue must not be compressed past the mechanical breaking point of tissue beyond which the tissue loses
elasticity and its mechanical behavior under compressive (for hemostasis) and tensile (for leak prevention) loads
becomes unpredictable at best.
(2) The upper limit of tissue thickness ranges specified in the IFUs of the currently marketed stapling products,
determined arbitrarily without scientific support, corresponds to the level of tissue compression well beyond the
breaking point of any tissue of organ commonly subject to stapling operation irrespective of the organ type.
(3) A spot checker device, an adjunct for the currently marketed hand-held as well as robotic assisted stapling
products, for inspecting staple line for presence of localized tissue compressed past the breaking point and
potentially in unstable condition is to be made available.
FALSE SENSE OF EFFICACY | UNSUBSTANTIATED CLAIMS OF UNIVERSAL APPLICABILITY
(1) Manufacturers of the currently marketed surgical stapling products maintain their various surgical stapling
products developed relying commonly upon, essentially, a single basic design principle are universally applicable to
any and all organs these products are indicated for without scientific basis.
(2) Given differences in anatomical and physiological characteristics of the organs it would be illogical to assume that
a single design principle could ensure effective clinical performance of various surgical stapling products of any one
manufacturer irrespective of the type of organ.
PROGRESS IN IMAGINATION | A (MISSING) KEY CONSIDERATION IN THE DESIGN OF STAPLING SYSTEM
(1) The tissue in staple line must be able to cope with: (a) the localized, quasi-static load in the blood vessel peaking at
the (patient-specific) systolic pressure (for hemostasis) and (b) the organ-wide dynamic (and highly periodic in the
case of the lung making the staple line susceptible to damage due to resonance) load due to physiological motion of
the organ (for leakage prevention).
(2) It is not scientifically clear how the steps or bumps introduced on the deck of staple cartridges or formed staples
with offset legs of the currently marketed stapling products help improve the performance of staple line over the one
created with the flat-deck staple cartridge with conventional formed staple shape*.
(3) No meaningful technological progress for the surgical stapling products has been made to directly address the
safety issues raised by the FDA in October 2021.
UNCLEAR OUTLOOK 1 | GEOMETRIC IRREGULARITIES ON THE DECK OF STAPLE CARTRIDGE
(1) Irregular geometric features over the flat-deck of a staple cartridge, such as slopes or bumps on the currently
marketed stapling products, make significantly complicated the technical design of devices and algorithms for
providing capabilities for the surgeon to make an informed selection of staple cartridge based on the measured
mechanical property of target tissue.
(2) Irregular geometric features over the flat-deck of a staple cartridge also seriously complicate the technical
aspects of adaptation of the currently marketed stapling products to the anatomy and physiology of target organ
likely rendering it unachievable.
UNCLEAR OUTLOOK 2 | VARIATION IN THE SHAPE OF FORMED STAPLES IN STAPLE LINE
(1) Variation in the shape of formed staples in staple line such as offset legs, arbitrarily introduced without scientific
basis, could hamper and make technically complicated future technological development efforts to incrementally
improve the staple line to be better able to meet the functional performance requirements of staple line that vary
significantly depending on the type of organ targeted for stapling operation.
(2) Variation in the shape of formed staples in staple line also seriously complicate the technical aspects of adaptation
of the currently marketed stapling products to the anatomy and physiology of target organ likely rendering it
unachievable.
UNCLEAR OUTLOOK 3 | COMPOUNDING THE PROBLEMS
(1) Irregular geometric features over the flat-deck of a staple cartridge combined with variation in the shape of formed
staples in staple line only worsen the existing problems of currently marketed surgical stapling products.
(2) Arbitrary introduction of superficial features without scientific basis to the currently marketed surgical stapling
products may provide an illusion of technological progress and serve a side purpose of product differentiation but
such practice is known to be unsustainable and only serves to impede much needed real progress.
* See Section "Path Forward | The Basics".
Path Forward | The Last Word
THE PLAIN TRUTH | DO IT RIGHT THE FIRST TIME
(1) A scientific foundation for any technological product, including the currently marketed surgical stapling products,
simply cannot be built after the fact.
(2) A scientific foundation for any technological product must be clearly and firmly established at the earliest possible
stage of product development cycle certainly before initial conceptual design of the product.
THE ONLY PATH FORAWRD | FIRSTLY, A STEP BACKWARD (to "The Zeroth Step")
(1) The currently marketed surgical stapling products must be returned back to the baseline state to: (a) re-establish
the safety and effectiveness baseline, historically established in the real world, of the art of surgical stapling and (b)
restart a methodical and focused technological development effort to bring about a generational change to the art of
surgical stapling.
(2) The slopes and bumps on the deck of staple cartridge and the staples with offset legs, arbitrarily introduced
without scientific basis, must be removed from the currently marketed surgical stapling products.
THE INCOVENIENT TRUTH REGARDING THE REGULATORY FRAMEWORK | BETTER LATE THAN NEVER
(1) The manufacturers of currently marketed surgical stapling products claim a lot higher level of clinical performance
capabilities of their products, without providing scientific basis, than the current regulatory framework could
possibly provide assurance for in safety and efficacy.
(2) The regulatory framework for currently marketed surgical stapling products must be updated to reflect the
advancements in the stapling technologies over the years and to restrain the unsubstantiated clinical performance
claims by the manufacturers.
. . . . .
LOCATIONS
Santa Clara, CA
Feel free to contact us with questions or comments!
* The products displayed on this website are under development and have not been cleared or approved for marketing by any regulatory agency. The contents of
this website may be updated in the future without prior notice.
