BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN SGS

    MDR report key: 15544722 · Received October 5, 2022

    Report

    Report Number
    3012481535-2022-00007
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 5, 2022
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE LOAD ON THE FIRING SYSTEM THE DEVICE PAUSED FIRING AND INSTRUCTED THE USER TO MANUALLY BAILOUT AS THE DESIGN IS INTENDED TO WORK. BASED ON THE COMPLAINT DESCRIPTION, THE SURGEON DID NOT FOLLOW SEQUENCE OF MANUAL BAILOUT DIRECTIONS, AS NOTED IN THE TITAN STAPLER IFU, L0015. THE KNIFE SHALL BE RETURNED TO THE START POSITION PRIOR TO OPENING THE JAWS. IN THIS CASE, THE JAWS WERE OPENED FIRST AND DAMAGE TO THE CLOSURE SYSTEM WAS REPORTED BY THE USER. THIS LIKELY OCCURRED DUE TO EXCESSIVE LOAD BEING APPLIED TO THE CLOSURE SYSTEM. THE COMPLAINT DEVICE WAS SCRAPPED AFTER THE PROCEDURE. THEREFORE, THE INVESTIGATION WAS BASED ONLY ON THE COMPLAINT DESCRIPTION, COMMUNICATION WITH USER, AND ASSOCIATED SPU DATA PROVIDED. 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

    A LAPAROSCOPIC SLEEVE PROCEDURE WAS BEING COMPLETED ON A PATIENT WITH AN UNUSUALLY THICK STOMACH. ACCORDING TO THE SURGEON, THE SURGEON HAD TROUBLE CLOSING THE JAWS OF THE DEVICE ON THE STOMACH. UPON FIRING, HE RECEIVED "HIGH LOAD DETECTED". THE SURGEON THEN PROCEEDED TO MANUALLY FIRE DEVICE AND ENCOUNTERED 1 MORE "HIGH LOAD DETECTED" AT 50% COMPLETE. THE "BAIL OUT" AUDIO PROMPT WAS HEARD, AND THE SURGEON PROCEEDED TO MANUALLY BAIL OUT THE DEVICE. SURGEON USED THE BAIL OUT CHUCK KEY ON TOP GEAR FIRST MISTAKENLY AND BROKE TOP GEAR AND THEN HE PROCEEDED TO RESET KNIFE BLADE. ACCORDING TO THE SURGEON, AFTER THE TITAN SGS DEVICE WAS OPENED, THE SURGEON COULD NOT CLOSE THE DEVICE. AS A RESULT, THE SURGEON HAD TO INCREASE SKIN INCISION AND REMOVE DEVICE AND TROCAR ALL AT ONCE. A LEXINGTON MEDICAL STAPLER WAS USED TO FINISH THE SLEEVE WITH X5 RELOADS (60MM). SURGERY WAS COMPLETED AND AN EXTRA STITCH IN FASCIA DUE TO THE TROCAR SITE INCISION INCREASE. NO ADDITIONAL PATIENT CONSEQUENCE OR ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077470 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE, PRODUCT CODE: GDW GDW STANDARD BARIATRICS SGS23R 125-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention