BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFORM

    MDR report key: 16303998 · Received February 6, 2023

    Report

    Report Number
    2955842-2023-10515
    Event Type
    Death
    Date Received
    February 6, 2023
    Date of Event
    January 6, 2023
    Report Date
    January 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. HOWEVER, THE CUSTOMER REPORTED THAT THE BLUE SUREFORM 60 RELOADS FIRED DURING THIS PROCEDURE WERE DISCARDED, AND THEREFORE CANNOT BE RETURNED FOR FURTHER INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE HAS BEEN PERFORMED BY A TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED COMPLAINT WITH NO SERVICE REQUESTS BEING CREATED. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE ON (B)(6) 2023. AS A RESULT OF THIS REVIEW, THE TSE DID NOT RECOMMEND A FIELD SERVICE ENGINEER (FSE) VISIT THE SITE TO PERFORM SYSTEM VERIFICATION TESTING. AN ISI FAILURE ANALYSIS ENGINEER (FAE) REVIEWED THE STAPLER LOGS FOR THE STAPLER USED IN THIS EVENT AND THE FOLLOWING INFO WAS PROVIDED: THE LOGS SHOW A SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM (ARM #1 AND #3) EIGHT TIMES AND FIRED 7 RELOADS (3 BLUE, FOLLOWED BY 4 WHITE). ON INSTALL 1, THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, A WHITE RELOAD WAS LOADED, AND THERE WERE 3 INCOMPLETE CLAMPS OUT OF 3 CLAMP ATTEMPTS. COMPLETION PERCENTAGES WERE AROUND 54%, 57%, AND 57% RESPECTIVELY. A RELOAD WAS NOT FIRED ON THIS INSTALL. ON INSTALL 3, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR AND THE USER MANUALLY SELECTED THE BLUE RELOAD VIA THE USER INTERFACE ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. THERE WAS A COMPLETED CLAMP FOLLOWED BY A COMPLETED FIRING WITH 1 PAUSE FOR COMPRESSION. THERE WERE NO MORE INCOMPLETE CLAMPS, NO INCOMPLETE UNCLAMPS, OR FIRING FAILURES FOR THIS INSTRUMENT. FIRING ON INSTALL 4 WAS COMPLETED WITH NO PAUSES FOR COMPRESSION, WHILE ON INSTALLS 5-8 FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION ON EACH. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. A MEDICAL REVIEW WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: "ACCORDING TO THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THE STAPLE LINE OF THE GASTRIC POUCH LEAKED LEADING TO A SECOND OPERATION ON POST OPERATIVE DAY 5. THE PATIENT WAS IN CRITICAL CONDITION AND EVENTUALLY EXPIRED ON POST OPERATIVE DAY 6. BASED ON THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY ISI PRODUCTS CONTRIBUTED TO THE DEATH OF THIS PATIENT." THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, THE PATIENT EXPERIENCED A STAPLE LINE LEAK. AS A RESULT, THE PATIENT RECEIVED A SECONDARY PROCEDURE. HOWEVER, THE PATIENT EXPIRED THE DAY AFTER THIS SECONDARY PROCEDURE. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE REPORTED INTRA-OPERATIVE BLEEDING STAPLE LINE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED IN SECTIONS A2, A4, A6, B6, B7, E1, E3, ANNEX E CODES, AND H10 BELOW (FOR B5). INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE PATIENT SAFETY SPECIALIST (PSS) AND ADDITIONAL INFORMATION WAS OBTAINED: THE PSS SAID THAT THEY FOUND, DURING THEIR INVESTIGATION, THE REPORTED INTRA-OPERATIVE BLEEDING FROM THE HORIZONTAL STAPLE LINE WAS INACCURATE. IT WAS REPORTED THAT NO INTRA-OPERATIVE BLEEDING WAS DOCUMENTED FOR THIS PROCEDURE. THE INDICATION FOR THIS PROCEDURE WAS MORBID OBESITY. IT IS UNKNOWN WHAT CAUSED THE PRESSURE BUILD UP AT THE JEJUNAL JUNCTION (JJ). IT WAS STATED THAT THE JUNCTION COULD HAVE BEEN CREATED TOO NARROW, OR IT COULD HAVE BEEN DUE TO EDEMA OF THE TISSUE. IT WAS REPORTED THAT THERE WAS NOTHING OF CONCERN NOTED DURING THE ORIGINAL OPERATION. ON POST-OPERATIVE DAY (POD) 5, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING DIFFICULTY DRINKING FLUIDS, FOLLOWED BY ABDOMINAL PAIN. THE PATIENT WAS DIAGNOSED WITH SEPSIS. A CT SCAN UPON ADMISSION SHOWED NO FREE-FLUID. A SECOND CT WAS LATER PERFORMED AND IT WAS REPORTEDLY DIFFICULT TO TELL IF THE STAPLE LINE WAS UNDONE AT THAT TIME. AN EXPLORATORY LAPAROTOMY-CONVERTED TO OPEN SURGERY WAS PERFORMED WHERE IT WAS FOUND THAT THE VERTICAL STAPLE LINE (STAPLED PORTION OF THE STOMACH) HAD OPENED UP. THE SITE WAS REPAIRED, A GASTRIC FEEDING TUBE WAS PLACED, THE ABDOMEN WAS WASHED OUT, AND DRAINS WERE PLACED. ON POD 6 THE PATIENT EXPIRED WITH THE ULTIMATE CAUSE OF DEATH REPORTED AS SEPSIS DUE TO INTRA-ABDOMINAL LEAK/PERFORATION. AN AUTOPSY WAS NOT PERFORMED. THE SURGEON BELIEVES THE SUREFORM 60 STAPLER INSTRUMENT AND BLUE RELOAD ARE RELATED TO THIS EVENT FROM PRESSURE ON THE STAPLE LINE POST-OPERATIVELY AND THE STAPLE LINE JUST OPENED UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) PROCEDURE, A VERTICAL STAPLE LINE OF THE GASTRIC POUCH CAME UNDONE AT THE JJ-JUNCTION. THE PATIENT RECEIVED A SECONDARY PROCEDURE ON POST-OPERATIVE DAY (POD) #5 AND WAS IN CRITICAL STATUS. THE PHYSICIAN¿S ASSISTANT (PA) REPORTED THAT THE PATIENT EXPIRED ON POD #6. THE PA REPORTEDLY CHECKED THE SURGICAL NOTES FOR THE INITIAL GASTRIC BYPASS PROCEDURE AND SAW THAT THERE WAS MENTIONING OF INTRA-OPERATIVE BLEEDING FROM THE HORIZONTAL STAPLE LINE WHERE A BLUE SUREFORM 60 RELOAD HAD BEEN FIRED, AND THAT THE VERTICAL STAPLE LINE WAS ALSO MADE WITH A BLUE SUREFORM 60 RELOAD. HOWEVER, NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED WITH THE VERTICAL LINE. THERE WAS NO DOCUMENTATION OF SEAM GUARD BEING USED WITH ANY OF THE STAPLE LINES. THE PA SAID THE STAPLER RELOADS AND SUREFORM 60 STAPLER INSTRUMENT USED DURING THIS PROCEDURE WERE DISCARDED, AND THEY DO NOT DOCUMENT THE LOT NUMBER OF WHICH RELOAD WAS USED TO CREATE WHICH STAPLE LINES. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON OF THIS PROCEDURE; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113758 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES