BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 19009047 · Received March 30, 2024

    Report

    Report Number
    3012481535-2024-00002
    Event Type
    Injury
    Date Received
    March 30, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 26, 2024
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON EVALUATED THE PATIENT DEMOGRAPHICS, COMORBIDITIES, SENSITIVITY TO HEPARIN AND THE POST OPERATIVE LENGTH OF TIME AND DETERMINED THE REPORTED EVENT WAS NOT RELATED TO THE STAPLING INSTRUMENT.

    Description of Event or Problem · 0

    THE INITIAL SLEEVE GASTRECTOMY PROCEDURE WAS COMPLETED ON (B)(6) 2024 AND 28 DAYS POST-OPERATIVELY, THE PATIENT PRESENTED WITH VOMITING. THE PATIENT WAS READMITTED WITH A HEMATOMA AND STAPLE LINE BLEED THAT WAS DISCOVERED VIA CT. DRAINS AND CLIPS WERE PLACED ALONG THE STAPLE LINE IN AREAS WHERE THE HEMATOMA WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583923 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R