BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 2941398 · Received January 29, 2013

    Report

    Report Number
    MW5028804
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HANDLE SPLIT OPEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39511 COVIDIEN ENDO CLIP AUTO SUTURE CLIP APPLIER FZP COVIDIEN J2G0058X

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR