BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 14640209 · Received June 8, 2022

    Report

    Report Number
    2955842-2022-12069
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 11, 2022
    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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THE CUSTOMER REPORTED THAT THE SUREFORM 60 STAPLER INSTRUMENT AND WHITE STAPLER RELOAD USED DURING THIS EVENT WERE BOTH DISCARDED AND THEREFORE CANNOT BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ISI FAILURE ANALYSIS ENGINEER REVIEWED THE STAPLER INSTRUMENT LOGS FOR THIS EVENT: THE LOGS SHOW THAT SUREFORM 60 STAPLER INSTRUMENT (PART #480460-09, LOT #T92220211-0179 WAS INSTALLED 8 TIMES AND FIRED 8 RELOADS (6 BLUE FOLLOWED BY 2 WHITE). ALL FIRINGS WERE COMPLETED PER THE LOGS WITH EITHER 0 OR 1 PAUSES FOR COMPRESSION (BOTH WHITE FIRINGS HAD 1 PAUSE). THERE WERE NO INCOMPLETE CLAMPS BY THIS STAPLER INSTRUMENT. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY TWO DUE TO A STAPLE LINE BLEED. THE PATIENT REPORTEDLY LOST THREE UNITS OF BLOOD. NO TRANSFUSIONS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATION DAY TWO DUE TO A STAPLE LINE BLEED. THE PATIENT REPORTEDLY LOST THREE UNITS OF BLOOD, BUT RECEIVED NO TRANSFUSIONS. THE PATIENT IS REPORTEDLY IN GOOD HEALTH AND HAS BEEN DISCHARGED. THE SURGEON HAD USED A WHITE SUREFORM 60 RELOAD WITH A SUREFORM 60 STAPLER INSTRUMENT DURING THE SURGICAL PROCEDURE. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE SURGEON PERFORMED AN ANASTOMOSIS ON THE JEJUNUM USING A WHITE SUREFORM 60 RELOAD WITH A SUREFORM 60 STAPLER INSTRUMENT. THE SURGEON BELIEVES WHITE RELOAD CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE BLEED. THE SURGEON REPORTED THERE WERE NO COMPLICATIONS WITH THIS STAPLE LINE DURING THE PROCEDURE AND IT APPEARED IN GOOD CONDITION AFTER BEING FIRED. THE USED DURING THIS EVENT WERE BOTH DISCARDED AND THEREFORE CANNOT BE RETURNED. THE PATIENT RECEIVED OBSERVATION AND TRANEXAMIC ACID TO RESOLVE THIS EVENT. THE SURGEON SAID THERE IS NO CONCERN FOR ANY LONG-TERM COMPLICATIONS WITH THIS PATIENT. THERE ARE NO PHOTOS OR VIDEOS OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632033 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-06 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES