BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR FORCEPS MCEN54 120MM DESSI [MXI]

    MDR report key: 3437637 · Received October 30, 2013

    Report

    Report Number
    9680837-2013-00489
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 8, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: BIPOLAR FORCEPS MCEN54 120MM DESSI, 510K: K993655, SERIAL #: NOT APPLICABLE, LOT#: 121101, MANUFACTURED NOV. 2012. (B)(4). THE FINDINGS OF THE PRODUCT ANALYSIS INDICATE THAT THE COATING/INSULATION HAS PROBABLY BEEN DAMAGED BY AN EXCESSIVE ABRASION OR FRICTION DURING THE USE OR DURING THE REPROCESSING STEPS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER EXPERIENCED A "PROBLEM OF LOSS OF COAGULATION WITH A BURNING SMELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557913 BIPOLAR FORCEPS MCEN54 120MM DESSI [MXI] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG MCEN54 120401

    Patients

    Seq Age Sex Outcome Treatment
    1