BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 17720195 · Received September 11, 2023

    Report

    Report Number
    3012481535-2023-00004
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    April 25, 2023
    Report Date
    August 28, 2023
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HIGH LOADS WERE HIT DURING THE PROCEDURE USING THE TITAN SGS STAPLER AND THE STAPLER WAS THEN UNPLUGGED AND REPLUGGED INTO THE SPU. SOME PROMPTS WERE HEARD BY THE SURGEON BUT THE PROMPTS WERE NOT SPECIFIED IN THE REPORT. THE SURGEON NOTICED BLEEDING AT THE ANGULARIS DURING THE INTITIAL SURGERY AND THEN THE SURGEON REPORTED A BLEED 6 DAYS POST-OPERATION. AN INTERNAL DRAIN WAS PLACED TO TREAT THE HEMATOMA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143267 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H