BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1171556 · Received September 17, 2008

    Report

    Report Number
    2248146-2008-00093
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    DATASCOPE CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC TIP ON THE JAWS OF THE BIPOLAR DEVICE BROKE OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE ENDO VESSEL HARVESTING GEI DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK