BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 15157098 · Received August 3, 2022

    Report

    Report Number
    3012481535-2022-00002
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 3, 2022
    Manufacturer
    STANDARD BARIATRICS, INC
    Product Code
    GDW
    UDI-DI
    00851677007089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, A SMALL LEAK AT THE GE JUNCTION WAS CONFIRMED VIA CT SCAN FOR A PATIENT WHO SHOWED UP AT THE ER WITH ABDOMINAL PAIN. THE PATIENT HAD RECEIVED A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHICH USED THE TITAN SGS23R STAPLER, APPROXIMATELY TWO WEEKS PRIOR TO THE EVENT. THE PATIENT WAS HOSPITALIZED, GIVEN FLUIDS ALONG WITH GETTING A PERC DRAIN. A STENT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013977 TITAN SGS STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS, INC SGS23R 077-22 00851677007089

    Patients

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