BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 17719250 · Received September 11, 2023

    Report

    Report Number
    3012481535-2023-00006
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    June 30, 2023
    Report Date
    September 6, 2023
    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

    Additional Manufacturer Narrative · 0

    FOLLOWING ANALYSIS OF THE COMPLAINT DEVICE, THE FINDINGS WERE SHARED WITH THE SURGEON ASSOCIATED WITH THE COMPLAINT. DURING THE INSTRUCTED BAILOUT PROCESS, THE SURGEON DID NOT FEEL THAT EXCESSIVE FORCE WAS APPLIED TO CAUSE THE DAMAGE AND THAT IF THE DESIGN MEETS THE MANUFACTURER'S CURRENT SPECIFICATIONS, FURTHER INVESTIGATIONS INTO THE THOSE SPECIFICATIONS SHOULD BE EVALUATED.

    Additional Manufacturer Narrative · 0

    UPON EVALUATION OF THE TITAN SGS STAPLER, 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 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 HARD FIRING LIMIT AT ABOUT 50% FIRING AFTER HITTING A SOFT FIRING LIMIT. THE KNIFE BLADE WAS RETRACTED AND THE JAWS OF THE DEVICE WERE OPENED, BUT WHEN ATTEMPTING TO CLOSE THE JAWS, THE SILVER COUPLER BROKE OFF. THE JAWS OF THE DEVICE WERE NOT ABLE TO BE CLOSED. THE TROCAR INCISION WAS INCREASED TO REMOVE THE DEVICE FROM ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138822 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R 208-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention