BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20421580 · Received October 10, 2024

    Report

    Report Number
    2955842-2024-20516
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 17, 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
    IL, 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. AN ADVANCED STAPLER LOG INVESTIGATION BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) REVEALED THE FOLLOWING: THE LOGS SHOW A SUREFORM 60 STAPLER INSTRUMENT (PART#: 480460-09, LOT#: K16240418-0543) WAS INSTALLED ON THE SYSTEM 6 TIMES AND FIRED 6 RELOADS (1 BLUE, FOLLOWED BY 5 WHITE). ON INSTALLS 1-5, ALL CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 6, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED, AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE STAPLE LINE WHERE A WHITE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT LEAKED POSTOPERATIVELY. THE WHITE SUREFORM 60 RELOAD WAS THE LAST FIRING OF THE STAPLER INSTRUMENT. A POSTOPERATIVE SWALLOW STUDY WAS CONDUCTED AND FOUND TO BE NORMAL. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924849 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.