BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 15853960 · Received November 23, 2022

    Report

    Report Number
    3012481535-2022-00009
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 23, 2022
    Manufacturer
    STANDARD BARIATRICS, INC.
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED DURING INITIAL CASE, THEREFORE, THE DEVICE WAS NOT ABLE TO BE INVESTIGATED. DHR REVIEW FOR REPORTED LOT WAS EVALUATED AND THERE WERE NO INDICATIONS THAT THE DEVICE CONTRIBUTED TO THE COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT WAS RETURNED TO SURGERY ON THE SAME EVENING, FOLLOWING AN INITIAL SLEEVE GASTRECTOMY PROCEDURE PERFORMED EARLIER IN THE DAY, WHICH HAD USED THE TITAN STANDARD GASTRIC STAPLER. DURING THE INITIAL CASE, NO STAPLE LINE BLEEDING WAS OBSERVED. THAT EVENING, THE PATIENT WAS RETURNED TO SURGERY AND TWO LITERS OF BLOOD REMOVED. BLEEDING WAS OBSERVED AT TWO LOCATIONS, ONE AT THE ANTRUM AND ONE JUST BELOW THE OMENTOPEXY THAT WAS PERFORMED DURING THE INITIAL CASE EARLIER THAT DAY. THE BLEEDING LOCATIONS WERE IDENTIFIED AS PIN HOLE BLEEDING SITES. CLIPS WERE APPLIED AND FLOSEAL WAS USED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND NO ADDITIONAL PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291826 TITAN SGS STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS, INC. SGS23R 141-22

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H