BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE MCL59 BAYONET MONOPOLAR FRECHE [MXI/XOM]

    MDR report key: 3113547 · Received May 15, 2013

    Report

    Report Number
    1045254-2013-00383
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN UNUSED FRECHE NEEDLE WAS OPENED, UPON INSPECTION, THE INSULATION AT THE TIP OF THE INSTRUMENT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214792 KNIFE MCL59 BAYONET MONOPOLAR FRECHE [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED, INC MCL59 201111MF2

    Patients

    Seq Age Sex Outcome Treatment
    1