BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 19444267 · Received June 1, 2024

    Report

    Report Number
    3012481535-2024-00003
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 29, 2024
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    UDI-DI
    00851677007089
    PMA / PMN Number
    K210278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER THE STAPLE LINE WAS COMPLETED USING THE TITAN STAPLER, THE JAWS COULD NOT BE OPENED WITH TRIGGER UP. THE SURGEON THEN ATTEMPTED TO MANUALLY BAIL OUT. THE JAWS WERE ABLE TO BE OPENED SLIGHTLY, BUT THE CLOSURE COUPLER CAME LOOSE AND FELL OUT OF THE DEVICE. THE JAWS COULDN'T BE OPENED FURTHER, ALTHOUGH, THE OPENING WAS LARGE ENOUGH TO REMOVE THE STOMACH FROM BETWEEN THE JAWS. MULTIPLE ATTEMPTS WERE MADE UNSUCCESSFULLY TO PLACE THE COUPLER BACK INTO PLACE. FORCEPS WERE THEN USED TO EXPAND THE TROCAR INCISION SITE FOR TITAN EXTRACTION. EXTRACTION WAS SUCCESSFUL AND THE TITAN STAPLER WAS ABLE TO BE REMOVED. CAUTERY WAS APPLIED AND PORT SITE WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319550 TITAN SGS SURGICAL STAPLER WITH STAPLE GDW STANDARD BARIATRICS SGS23R 194-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention