BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 17374833 · Received July 21, 2023

    Report

    Report Number
    17374833
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 14, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    UDI-DI
    10884523003154
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING BARIATRIC PROCEDURE, THE COVIDIEN ENDO GIA STAPLE LOAD WOULD NOT LATCH ONTO THE INSTRUMENT. ANOTHER STAPLE LOAD WAS HANDED UP ONTO THE FIELD AND WORKED WITHOUT DIFFICULTY.

    Description of Event or Problem · 0

    DURING BARIATRIC PROCEDURE, THE COVIDIEN ENDO GIA STAPLE LOAD WOULD NOT LATCH ONTO THE INSTRUMENT. ANOTHER STAPLE LOAD WAS HANDED UP ONTO THE FIELD AND WORKED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148232 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP EGIA45AMT P2M0355 10884523003154

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA Female