BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFORM

    MDR report key: 17936497 · Received October 13, 2023

    Report

    Report Number
    2955842-2023-19208
    Event Type
    Death
    Date Received
    October 13, 2023
    Date of Event
    September 14, 2023
    Report Date
    September 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, A ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE PHYSICIAN STATED THE STAPLE LINE FAILED AFTER THE PATIENT ASPIRATED. REVIEW OF THE ADVANCED STAPLER LOGS SHOW THE SUREFORM 60 INSTRUMENT WAS INSTALLED ON THE SYSTEM TWICE AND FIRED 1 BLUE RELOAD. ON THE FIRST INSTALL, A BLUE RELOAD WAS LOADED, HOWEVER NO CLAMPING OR FIRING WAS PERFORMED. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED. THERE WERE NO RELEVANT ERRORS IN THE SYSTEM LOGS FOR THIS PROCEDURE. THE INSTRUMENTS NOTED BELOW WERE USED DURING THE REPORTED PROCEDURE. REVIEW OF THE INSTRUMENT LOGS FOUND THAT THE FOLLOWING MULTIPLE USE DEVICES WERE USED IN SUBSEQUENT PROCEDURES AFTER THE EVENT DATE WITH NO REPORTED COMPLAINTS AND HAVE LIVES REMAINING: ENDOSCOPE PLUS 30 DEGREE, MEGA SUTURECUT NEEDLE DRIVER, AND MONOPOLAR CURVED SCISSORS. A PERMANENT CAUTERY HOOK AND MARYLAND BIPOLAR FORCEPS HAVE LIVES REMAINING BUT WERE NOT USED IN SUBSEQUENT PROCEDURES. A MULTIPLE USE FENESTRATED BIPOLAR FORCEPS HAD 0 LIVES REMAINING AFTER THE EVENT; AND VESSEL SEALER EXTEND AND SUREFORM 60 STAPLER INSTRUMENTS ARE SINGLE-USE AND THEREFORE NONE OF THESE INSTRUMENTS WERE USED IN SUBSEQUENT PROCEDURES. AN ADVANCED SYSTEM LOG REVIEW FOR THE REPORTED EVENT DATE SHOWED THAT THERE WERE NO RELEVANT ERROR MESSAGES RELATED TO THE REPORTED EVENT. AT THE TIME OF THE REVIEW THERE WERE 15 SUBSEQUENT PROCEDURES PERFORMED WITH THE SYSTEM AFTER THE REPORTED PROCEDURE, ALSO WITH NO RELEVANT ERRORS CAPTURED. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THE PATIENT DIED ON POST-OPERATIVE DAY 2 AFTER A GASTROJEJUNOSTOMY. THERE IS MINIMAL ADDITIONAL INFORMATION REGARDING THE INDICATIONS FOR THE OPERATION, HOW THE PROCEDURE WAS PERFORMED, ANY ISSUES WHICH MAY HAVE ARISEN DURING THE SURGERY, OR HOW THE POST OPERATIVE COURSE PROGRESSED OTHER THAN THE PATIENT ASPIRATED AND A STAPLE LINE FAILED. HOW THESE TWO EVENTS OCCURRED, HOW THEY MAY OR MAY NOT HAVE BEEN RELATED, OR WHEN THEY WERE DISCOVERED WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED GASTROJEJUNOSTOMY, THE PATIENT EXPIRED. THE SURGEON INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT ON POSTOPERATIVE DAY (POD) 2, WHILE STILL ADMITTED TO THE HOSPITAL, THE PATIENT ASPIRATED, THE STAPLE LINE FAILED, AND THE PATIENT EXPIRED. AT THE TIME, THE SURGEON DID NOT KNOW IF THE ROBOT CONTRIBUTED OR NOT AND NO ADDITIONAL DETAILS WERE PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. ISI CONTINUES TO PERFORM FOLLOW UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748925 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.