BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 19583438 · Received June 21, 2024

    Report

    Report Number
    2955842-2024-15894
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN ADVANCED STAPLER LOG REVIEW SHOWS THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 7 TIMES AND FIRED 7 RELOADS (5 BLUE, FOLLOWED BY 2 WHITE). ON INSTALLS 1-5, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 6, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 7, THE FIRST TWO CLAMPS WERE SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN UNEVENTFUL DA VINCI ASSISTED ROUX-EN-Y, THE PATIENT EXPERIENCED HEMATOCHEZIA. THE SURGEON REPORTED NO INTRAOPERATIVE BLEEDING AT THE STAPLE LINE AND SAYS THE BLUE AND WHITE RELOADS WERE FIRED WITH NO PAUSES FOR COMPRESSION. HOWEVER, THE SURGEON IS WONDERING IF THE STAPLER MAY HAVE CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE BLEEDING. THE PATIENT IS BEING OBSERVED, BUT THUS FAR, THERE HAS BEEN NO SURGICAL INTERVENTION. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221506 SUREFORM STAPLER 60 RELOAD GDW INTUITIVE SURGICAL, INC 48360 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization DA VINCI INSTRUMENTS AND ACCESSORIES