BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS GASTRIC STAPLER

    MDR report key: 16743525 · Received April 13, 2023

    Report

    Report Number
    MW5116635
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 12, 2023
    Manufacturer
    STANDARD BARIATRICS, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE STAPLER STOPPED MID FIRING AND WOULD NOT PROCEED. AFTER TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL, THE EMERGENCY MECHANICAL ABORT FUNCTION WAS USED TO REMOVE THE STAPLER FROM THE TISSUE. THE PROCEDURE WAS COMPLETED USING AN ETHICON STAPLER AND THE CASE WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103016 TITAN SGS GASTRIC STAPLER STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS, INC. SGS23R 085-22

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male