BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TITAN SGS

    MDR report key: 14102630 · Received April 13, 2022

    Report

    Report Number
    3012481535-2022-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 13, 2022
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    UDI-DI
    00851677007089
    PMA / PMN Number
    K210278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO STANDARD BARIATRICS FOR EVALUATION. INVESTIGATION FOUND THAT THERE WAS DAMAGE TO THE CLOSURE SYSTEM WHICH LED TO THE DEVICE BEING INOPERABLE. THE ROOT CAUSE WAS ATTRIBUTED TO EXCESSIVE FORCE BEING APPLIED BY THE USER TO THE CLOSURE SYSTEM WHILE ATTEMPTING TO MANUALLY OPEN 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, THE ALLOWABLE TIME FOR FIRING WAS EXCEEDED FOR THE TITAN SGS SYSTEM WHICH PROMPTED THE USER TO MANUALLY BAIL OUT THE DEVICE. COMPLETE STOMACH RESECTION WAS ACHIEVED SUCCESSFULLY PRIOR TO THE TIME LIMIT BEING EXCEEDED. DURING MANUAL BAIL OUT AND USING THE BAILOUT KEY PROVIDED, THE USER RESET THE KNIFE, AND 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, WHICH RESULTED IN REQUIRING THE TROCAR INCISION SITE TO BE INCREASED APPROXIMATELY 1.5-2 INCHES TO ALLOW FOR THE REMOVAL OF THE TITAN SGS WITH THE JAWS IN THE OPEN POSITION. THERE WAS A DELAY IN PROCEDURE, APPROXIMATELY 10-15 MINUTES, BUT NO PATIENT INJURY OR CONSEQUENCE OTHER THAN EXTENSION OF SURGICAL INCISION < 2 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654265 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R 352-21 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention