BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    MDR report key: 3360713 · Received September 20, 2013

    Report

    Report Number
    9680837-2013-00473
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 26, 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

    CONCOMITANT: CEV133, FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA, LOT 130502, MFG DATE MAY 2013 2.CEV634-1A, BIPOLAR INSERT CEV634-1A 350MM MOUIEL, LOT 130613, MFG DATE JUNE 2013 3.CEV6795B, TUBE CEV6795B DIA 5MM 350MM, LOT 130504, MFG DATE MAY 2013. (B)(4): PRODUCT ANALYSIS WAS PERFORMED ON PART# CEV669B. AS PER THE ANALYSIS THE BLACK PLASTIC PIECE IS BURNT AT THE CONNECTION LEVEL. THE BURN OF THE PLASTIC IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). PRODUCT ANALYSIS WAS PERFORMED ON PART# CEV133. AS PER THE ANALYSIS "THE ELECTRODE HAD A SHORT CIRCUIT.¿ PRODUCT ANALYSIS WAS PERFORMED ON PART# CEV634-1 AND PART# CEV6795B. AS PER THE ANALYSIS "NO ISSUE WAS HIGHLIGHTED. INSTRUMENT WAS FOUND TO CONFORM TO MANUFACTURING SPECIFICATIONS".

    Description of Event or Problem · 1

    IT WAS REPORTED BIPOLAR FORCEPS CEV133 NOT WORKING, SMOKES/ ONE BIPOLAR FORCEPS CEV669B IS NOT WORKING AT ALL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474775 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 130603

    Patients

    Seq Age Sex Outcome Treatment
    1