BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 17831538 · Received September 28, 2023

    Report

    Report Number
    3012481535-2023-00009
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 26, 2023
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    UDI-DI
    00851677007089
    PMA / PMN Number
    K210278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON EVALUATION OF THE TITAN SGS, IT WAS DETERMINED THAT THE KNIFE WAS NOT FULLY REVERSED PRIOR TO OPENING THE JAWS, AS INSTRUCTED IN THE DEVICE INSTRUCTIONS FOR USE. CONSEQUENTLY, THE LOAD APPLIED TO THE CLOSURE SCREW WAS EXCESSIVE AND CAUSED IT TO BEND/DISTORT AS WELL AS CAUSING THE OBSERVED DAMAGED TO THE GEAR DURING THE OPENING OF THE JAWS OF THE TITAN STAPLER. THE INVESTIGATION FOUND THAT THE DAMAGE TO THE CLOSURE SYSTEM LED TO THE DEVICE BEING INOPERABLE. THE ROOT CAUSE WAS ATTRIBUTED TO THE KNIFE NOT BEING FULLY REVERSED AND EXCESSIVE FORCE/ROTATIONS BEING APPLIED BY THE USER TO THE CLOSURE SYSTEM WHILE ATTEMPING TO MANUALLY OPEN THE JAWS OF THE DEVICE USING THE BAILOUT KEY, RESULTING IN THE DEVICE BEING STUCK IN THE OPEN POSITION.

    Description of Event or Problem · 0

    THE TITAN STAPLER HIT A CRITICAL LOAD AFTER 2 HIGH LOAD WARNINGS OCCURRED. THE JAWS OF THE DEVICE WERE FULLY OPENED, BUT THE MANUAL BAILOUT TISSUE WAS STUCK DISTALLY. THE SURGEON CONTINUED TO TURN THE BAILOUT KEY AND THE CLOSURE COUPLER BROKE OFF. THIS LED TO THE TITAN BEING STUCK IN THE OPEN POSITION. THE 19 PORT SIZE WAS INCREASED SO THE OPEN TITAN COULD BE REMOVED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340510 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R 208-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention