BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 16882320 · Received May 5, 2023

    Report

    Report Number
    3012481535-2023-00001
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 18, 2023
    Manufacturer
    STANDARD BARIATRICS, INC.
    Product Code
    GDW
    UDI-DI
    00851677007089
    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

    THE PATIENT DEVELOPED A LEAK ON (B)(6) 2022 FOLLOWING A SLEEVE GASTRECTOMY PROCEDURE COMPLETED ON (B)(6) 2022, WHICH HAD USED THE TITAN SGS23R STAPLER. THE LOCATION OF THE LEAK WAS NOT ABLE TO BE CONFIRMED ALTHOUGH IT WAS REPORTED THAT AN OBSTRUCTION OCCURED AT THE MIDDLE PART OF THE STOMACH. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS THOUGHT TO BE NON-COMPLIANT. RE-OPERATION/SURGICAL INTERVENTION WAS COMPLETED HOWEVER NO DETAILS WERE REPORTED REGARDING SPECIFICALLY WHAT OCCURED DURING RE-OPERATION. IT WAS REPORTED THAT THE PATIENT WAS RELEASED AFTER RE-OPERATION/SURGICAL INTERVENTION. STANDARD BARIATRICS WAS NOTIFIED OF THIS EVENT ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195388 TITAN SGS STAPLE, IMPLANTABLE, PRODUCT CODE: GDW GDW STANDARD BARIATRICS, INC. SGS23R 165-22 00851677007089

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R