BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 15370883 · Received September 7, 2022

    Report

    Report Number
    3012481535-2022-00006
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 7, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 GASTRECTOMY PROCEDURE, AT THE BEGINNING OF FIRING MODE, A HIGH LOAD WAS DETECTED WHICH ULTIMATELY LED TO THE USER REQUIRING TO ENGAGE IN MANUAL BAILOUT OF THE TITAN SGS STAPLER. DURING MANUAL BAIL OUT AND USING THE BAILOUT KEY PROVIDED, THE USER WAS ABLE TO OPEN THE TITAN SGS JAWS TO RELEASE FROM THE STOMACH. THE USER WAS UNABLE TO CLOSE THE DEVICE USING THE BAILOUT KEY, AS THE BAILOUT KEY SPUN FREELY, WHICH RESULTED IN REQUIRING THE TROCAR INCISION SITE TO BE SLIGHTLY INCREASED TO ALLOW FOR THE REMOVAL OF THE TITAN SGS WITH THE JAWS IN THE OPEN POSITION. THE PROCEDURE WAS PROLONGED, APPROXIMATELY 5 MINUTES, TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STAPLER. THERE WAS NO ADDITIONAL PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717709 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANATABLE, PRODUCT CODE: GDW GDW STANDARD BARIATRICS SGS23R 103-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention