BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 15372254 · Received September 7, 2022

    Report

    Report Number
    3012481535-2022-00005
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 7, 2022
    Manufacturer
    STANDARD BARIATRIC, INC.
    Product Code
    GDW
    UDI-DI
    00851677007089
    PMA / PMN Number
    K210278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED THAT RESISTANCE WAS FELT WHEN TRYING TO CLOSE THE JAWS OF THE TITAN SGS STAPLER, WHICH IS INDICATIVE OF A BENT CLOSURE SCREW PROHIBITING THE MANUAL BAILOUT KEY FROM WORKING. UPON EVALUATION OF THE TITAN SGS, IT WAS DETERMINED THAT THE LOAD APPLIED TO THE CLOSURE SCREW WAS EXCESSIVE AND CAUSED IT TO BEND/DISTORT DURING THE OPENING OF THE JAWS OF THE TITAN SGS STAPLER, AS DAMAGE WAS OBSERVED. THE INVESTIGATION FOUND THAT THE DAMAGE TO THE CLOSURE SYSTEM LED TO THE DEVICE BEING INOPERABLE. THE ROOT CAUSE WAS ATTRIBUTED TO EXCESSIVE FORCE/ROTATIONS BEING APPLIED BY THE USER TO THE CLOSURE SYSTEM WHILE ATTEMPTING 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

    DURING A SLEEVE GASRECTOMY PROCEDURE, AT APPROXIMATELY 50% OF FIRING, A HIGH LOAD WAS DETECTED, WHICH ULTIMATELY LED TO THE USER REQUIRING TO ENGAGE IN MANUAL BAILOUT OF THE TITAN SGS STAPLER. DURING MANUAL BAILOUT AND USING THE BAILOUT KEY PROVIDED, THE USER SUCCESSFULLY RESET THE KNIFE AND OPENED THE JAWS TO REMOVE THE DEVICE FROM THE STOMACH. WHEN ATTEMPTING TO CLOSE THE DEVICE USING THE MANUAL BAILOUT KEY, RESISTANCE WAS FELT AND THE JAWS WERE UNABLE TO BE CLOSED, REQUIRING THE TROCAR INCISION SITE TO BE SLIGHTLY INCREASED TO ALLOW FOR REMOVAL OF THE TITAN SGS WITH THE JAWS IN THE OPEN POSITION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STAPLER. THERE WAS NO PATIENT INJURY OR CONSEQUENCE OTHER THAN EXTENSION OF THE SURGICAL INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431615 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRIC, INC. SGS23R 103-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention