BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE PRECISION BIPOLAR DEVICE

    MDR report key: 1171553 · Received September 17, 2008

    Report

    Report Number
    2248146-2008-00092
    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

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE TECH WAS UNABLE TO OPERATE JAWS. THE INNER SHAFT WAS TWISTED CAUSING THE JAWS NOT TO OPERATE. THE UPPER PLASTIC TIP OF THE JAWS WAS FOUND TO BE BROKEN OFF THE BIPOLAR DEVICE, THE BROKEN PORTION WAS NOT RETURNED. DRIED BLOOD WAS INSIDE THE SHAFT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE PRECISION BIPOLAR DEVICE ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI DATASCOPE CORP 0684-45-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK