BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 22501806 · Received July 14, 2025

    Report

    Report Number
    3012481535-2025-00002
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    July 11, 2024
    Report Date
    July 14, 2025
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS A FOLLOW-UP TO MDR 3012481535-2024-00004, ORIGINALLY SUBMITTED VIA WEBTRADER ON 24 JUL 2024. CONFIRMATION OF SUBMISSION WAS RECEIVED, INCLUDING ACKNOWLEDGEMENT 1 AND 2. HOWEVER, AS OF 14 JULY 2025, THIS REPORT DOES NOT APPEAR IN THE PUBLIC MAUDE DATABASE. THIS FOLLOW-UP IS BEING SUBMITTED TO ENSURE THE MDR IS APPROPRIATELY CAPTURED AND PUBLICLY AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED: 6 DAYS POST SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT PRESENTED BACK TO THE ER WITH COMPLAINTS OF WORSENING ABDOMINAL PAIN AND AN ELEVATED HEART RATE. A CT SCAN WAS PERFORMED AND SIGNS OF A LEAK WERE SEEN. AN OPERATIVE LAP CONFIRMED A LEAK. THE LOCATION OF THE LEAK WAS FOUND BY PERFORMING A BUBBLE TEST. THE HOLE WAS PINHOLE IN SIZE AND DIRECTLY ADJACENT TO THE STAPLE LINE NEAR THE GE JUNCTION. A PRIMARY REPAIR WAS PERFORMED WITH SUTURE. AFTER EVALUATION, IT WAS OBSERVED THAT THERE WAS APPROXIMATELY 1-2 CM OF TISSUE IN THE UPPER STOMACH/FUNDUS THAT COULD BE SAFELY REMOVED, THEREFORE, THE PRIMARY REPAIR WITH SUTURE WAS THEN RESECTED. THE INITIAL SLEEVE GASTRECTOMY PROCEDURE WAS ON (B)(6) 2024 AND THE LEAK WAS DISCOVERED ON (B)(6) 2024. A BUBBLE TEST WAS COMPLETED DURING THE ORIGINAL PROCEDURE AND THERE WERE NO INDICATIONS OF A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400955 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23RB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H