BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 16882147 · Received May 5, 2023

    Report

    Report Number
    3012481535-2023-00002
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 18, 2023
    Manufacturer
    STANDARD BARIATRICS, INC.
    Product Code
    GDW
    UDI-DI
    00851677007133
    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

    PATIENT DEVELOPED A LEAK ON (B)(6) 2023 FOLLOWING A SLEEVE GASTRECTOMY PROCEDURE COMPLETED ON (B)(6) 2023, WHICH HAD USED A TITAN SGS23RB STAPLER. A SMALL DEFECT WAS OBSERVED MORE POSTERIOR OF THE FUNDUS. IT WAS REPORTED THAT IT LOOKED LIKE THE FUNDUS WAS POSSIBLY FOLDED. RE-OPERATION/SURGICAL INTERVENTION WAS REQUIRED TO RESOLVE THE LEAK. THE PATIENT WAS RELEASED AFTER RE-OPERATION/SURGICAL INTERVENTION. STANDARD BARIATRICS WAS INFORMED OF THE LEAK ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212296 TITAN SGS STAPLE, IMPLANTABLE, PRODUCT CODE: GDW GDW STANDARD BARIATRICS, INC. SGS23RB 284-22 00851677007133

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H