BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO

    MDR report key: 3062773 · Received April 11, 2013

    Report

    Report Number
    MW5029763
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    TYCO
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5MM ENDOCLIP STAPLER (TYCO PRODUCT) JAMMED WHEN SURGEON ATTEMPTED TO USE IT. NEW STAPLER HAD TO BE OPENED. NO HARM TO PT. LOT # N9K0315.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155103 TYCO 5MM ENDOCLIP STAPLER FZP TYCO N9K0315

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR