BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN PROTACK DEVICE

    MDR report key: 6127379 · Received November 22, 2016

    Report

    Report Number
    MW5066300
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    June 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THREE PROTACKS WERE OPENED AND ALL FAILED TO LOAD TACKS - THE HANDLE WOULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771137 COVIDIEN PROTACK DEVICE COVIDIEN PROTACK DEVICE OCW COVIDIEN REF 174006 P6DO466X
    771138 COVIDIEN PROTACK DEVICE COVIDIEN PROTACK DEVICE OCW COVIDIEN REF 174006 P6DO466X
    771139 COVIDIEN PROTACK DEVICE COVIDIEN PROTACK DEVICE OCW COVIDIEN REF 174006 P6DO466X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR