BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 17720544 · Received September 11, 2023

    Report

    Report Number
    3012481535-2023-00007
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 25, 2023
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    UDI-DI
    00851677007089
    PMA / PMN Number
    K210278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 AS WELL AS CAUSING DAMAGE TO THE GEAR 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

    THE TITAN STAPLER HIT A CRITICAL HIGH LOAD AFTER CONSISTENT HIGH LOAD WARNINGS OCCURED. THE BAILOUT PROCESS WAS INITIATED BY A RESIDENT AND NEARLY COMPLETED SUCCESSFULLY. THE REMAINING PORTION OF THE PROCEDURE WAS COMPLETED WITH AN ETHICON STAPLER. WHEN THE RESIDENT TRIED TO CLOSE THE STAPLER USING THE BAILOUT KEY, THE SILVER KNOB DROPPED OUT OF THE STAPLER. THE SURGEON USED BOVIE AND TOWEL CLAMP TO GET OPEN STAPLER OUT OF ABDOMEN, AS WELL AS INCREASING THE TROCAR INCISION. THE PATIENT IS DOING WELL. A LEAK TEST WAS PERFORMED WITH NO SIGNS OF A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879450 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, PRODUCT CODE: GDW, PRODUCT CODE: GDW GDW STANDARD BARIATRICS SGS23R 271-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention