BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 8701390 · Received June 14, 2019

    Report

    Report Number
    1219930-2019-03481
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 14, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003154
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTROPLASTY, DURING THE BEGINNING OF THE SURGERY, THE DEVICE ONLY PERFORMED ONE SHOT THEN THE HANDLE HUNG UP AND BROKE. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493416 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AMT N8J0228KX 10884523003154

    Patients

    Seq Age Sex Outcome Treatment
    1