SUREFORM
Report
- Report Number
- 2955842-2024-10123
- Event Type
- Injury
- Date Received
- January 17, 2024
- Date of Event
- December 19, 2023
- Report Date
- December 19, 2023
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GDW
- UDI-DI
- 10886874113834
- PMA / PMN Number
- K173721
- Removal / Correction Number
- ISIFA2022-02-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A WHITE SUREFORM 60 RELOAD AND FIVE BLUE SUREFORM 60 RELOADS AND PERFORMED FAILURE ANALYSIS (FA) EVALUATION. THE SUREFORM 60 RELOADS WERE ANALYZED AND THERE WAS NO DAMAGE FOUND OR PRODUCT ISSUES IDENTIFIED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. ISI RECEIVED THE SUREFORM 60 STAPLER INSTRUMENT (PRODUCT #: 480460-09, LOT #: K17230727-0610) AND PERFORM FA EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE AN FAILED ENGAGEMENT WHEN PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED ENGAGEMENT 3 OUT OF 3 ATTEMPTS. ISI ALSO RECEIVED SUREFORM 60 STAPLER INSTRUMENT (PRODUCT #: 480460-09 , LOT #: K17230727-0590) AND PERFORMED FA EVALUATION. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT PASSED CLAMPING AND FIRING TEST. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE PASSED ENGAGEMENT WHEN PLACED ON THE IN-HOUSE SYSTEM. THE INSTRUMENT PASSED ENGAGEMENT 3 OUT OF 3 ATTEMPTS. A REVIEW OF THE LOGS REPORTED AN ERROR CODE INDICATING AN ENGAGEMENT FAILURE FOR THE STAPLER INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) #3. A REVIEW OF THE LOGS FOR THE SUREFORM 60 STAPLERS ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED, THE LOGS SHOW SUREFORM 60 STAPLER (PRODUCT #: 480460-09, LOT #: K17230727-0610), WAS USED FIRST AND IT WAS INSTALLED ON THE SYSTEM THREE TIMES AND FIRED THREE BLUE RELOADS. ON EACH INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THE LOGS SHOW THE SUREFORM 60 STAPLER (PRODUCT #: 480460-09, LOT #: K17230727-0590), WAS INSTALLED ON THE SYSTEM THREE TIMES AND FIRED TWO BLUE RELOADS. ON THE FIRST INSTALL, THE CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON THE SECOND INSTALL, THE STAPLER FAILED TO ENGAGE WITH THE SYSTEM. THE LOGS SHOW AN ERROR, INDICATING THAT THE WRIST PITCH AXIS FAILED TO ENGAGE. ON THE THIRD INSTALL, THE INSTRUMENT ENGAGED, THE CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO ADDITIONAL ERRORS PERTAINING TO THESE STAPLERS IN THE LOGS.
INTUITIVE SURGICAL, INC. (ISI) ADVANCE FAILURE ANALYSIS (AFA) INVESTIGATIONS WERE PERFORMED ON THE SUREFORM 60 STAPLER INSTRUMENT (LOT NUMBER: K17230727-0610) WHICH DID NOT CONFIRM THE INITIAL FINDINGS. THE PRODUCT WAS FOUND TO HAVE NO HISTORY OF PAST ENGAGEMENT FAILURES. FURTHERMORE, THE INSTRUMENT PASSED ALL IN-HOUSE TESTS WITHOUT ISSUE. AFA INVESTIGATIONS CONFIRMED THE INITIAL FINDINGS FOR THE RELOAD ACCESSORIES, AND ALSO FOUND FOR THE BLUE RELOAD ACCESSORY (BATCH: K10220821); THE BLADE WAS OBSERVED TO HAVE MECHANICAL INDENTATIONS ALONG THE ENTIRE LENGTH OF CUTTING EDGE; WITH LARGER INDENTATIONS NEAR THE BOTTOM AND TOWARDS THE TOP OF THE BLADE EDGE. BLADE DAMAGE IS NORMALLY ATTRIBUTED TO THE USER, BUT LACK OF DAMAGE TO OTHER COMPONENTS DOES NOT STRONGLY SUPPORT FIRING ACROSS AN OBSTRUCTION. THIS FINDING WAS UNRELATED TO THE PRIMARY EVENT WHICH WAS NOT VERIFIED BY FAILURE ANALYSIS. ADDITIONALLY, THIS RELOAD, ALONG WITH THE OTHER RELOADS FROM THE SAME CASE, WERE PASSED TO THE MECHANICAL DESIGN ENGINEERING TEAM FOR FURTHER INVESTIGATION, WHICH CONCLUDED WITH NO ABNORMAL FINDINGS OR ANOMALIES IDENTIFIED.
ADDITIONAL INFORMATION: AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE CONFIRMED THERE WERE NO RELATED ERRORS IN THE LOGS. THE GRIP AUTOCAL WAS CALIBRATED ON BOTH OF THE SURGEON SIDE CONSOLES (SSC), AND THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM3) WAS SWAPPED FOR USM4; FOR TROUBLE SHOOTING PURPOSES. NO PARTS WERE REPLACED, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AT A LATER DATE, THE FSE PREVENTATIVELY REPLACED THE INITIAL USM3 THAT WAS REPORTED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE USM3 TO PERFORM FAILURE ANALYSIS (FA) AND DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. NO FAULTS COULD BE IDENTIFIED THAT WOULD BE CONSISTENT WITH THE REPORTED FAILURE. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM, TESTED WITH A SUREFORM 45 STAPLER INSTRUMENT AND A SUREFORM 60 STAPLER INSTRUMENT, AND NO FAULTS OR ERRORS WERE DETECTED. THE UNIT WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM AND PASSED ALL RELEVANT TESTING WITHIN SPECIFICATION.
ADDITIONAL INFORMATION: FURTHER INVESTIGATION INTO THE UNIVERSAL SURGICAL MANIPULATOR (USM) FOUND THE TORQUE MEASUREMENT ON THE CARRIAGE GRIP DEGREES OF FREEDOM (DOF) EXHIBITED OUTPUT CONSISTENT WITH PRIOR VERIFICATION AND VALIDATION RESULTS AND ARE WITHIN SPECIFICATIONS. TESTING OF THE STAPLER CLAMPING FORCE ON STACKED CARDBOARD DID NOT EXHIBIT ANY NOTICEABLE DIFFERENCE IN DEFLECTION ON THE USM VERSUS OTHERS. THE CARRIAGE CALIBRATION VALUES WERE NORMAL. THE CARRIAGE WAS ELIMINATED AS A SUSPECT SOURCE OF THE INSUFFICIENT STAPLER CLAMP FORCE. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, WHILE USING THE SUREFORM 60 STAPLER INSTRUMENT WITH A BLUE SUREFORM 60 RELOAD, THERE WAS BLEEDING ON THE RESECTED END OF THE SMALL BOWEL ANASTOMOSIS. THIS WAS THE FIRST OCCURRENCE OF BLEEDING, BUT WAS RESOLVED WITH THE PLACEMENT OF CLIPS. THE SECOND OCCURRENCE WAS AFTER THE SIDE-TO-SIDE ANASTOMOSIS; THERE WAS A SMALL AMOUNT OF BLEEDING WHICH WAS RESOLVED USING A COUPLE OF CLIPS. HOWEVER, WHEN THE SURGEON VISUALIZED BOTH ANASTOMOSES, THERE WAS STILL SOME BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY TO BETTER VISUALIZE THE ANASTOMOSES. THE SURGEON DID NOT WANT TO PROCEED WITH THE ROBOT OR A THIRD PARTY LAPAROSCOPIC STAPLER. THE OPEN SURGERY WAS COMPLETED. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS AND HAS HAD NO POST-OPERATIVE COMPLICATIONS SINCE. HISTORICALLY, THE SURGEON DID NOT PREVIOUSLY USE CLIPS AFTER STAPLING. HOWEVER, THE SURGEON HAS SINCE CHANGED PRACTICES AND USES CLIPS AFTER STAPLING FOR ALL THE RIGHT HEMICOLECTOMY CASES, WHETHER THE PATIENT IS BLEEDING FROM THE STAPLE LINE OR NOT. REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2024-10122 (PATIENT IDENTIFIER # (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE SECOND OCCURRENCE OF BLEEDING AFTER USING THE SUREFORM 60 STAPLER INSTRUMENT WITH A BLUE SUREFORM 60 RELOAD.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405514 | SUREFORM | STAPLER 60 RELOAD BLUE | GDW | INTUITIVE SURGICAL, INC | 48360B-08 | K10220821 | 10886874113834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |