BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIACATCH

    MDR report key: 10747497 · Received October 28, 2020

    Report

    Report Number
    10747497
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 14, 2020
    Manufacturer
    COVIDIEN LP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ENTERING THE BELLY AND DEPLOYING THE COVIDIEN LP RELIACATCH SPECIMEN RETRIEVAL BAG, THE WIRES POPPED OUT OF THE RETRIEVAL BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210957 RELIACATCH LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN LP CATCH10 C1072420A

    Patients

    Seq Age Sex Outcome Treatment
    1 31025 DA