BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3364060 · Received September 24, 2013

    Report

    Report Number
    9680837-2013-00475
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 9, 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: CEV6795B TUBE CEV6795B DIA 5MM 350MM; LOT 130304; MFG 03/2013 2. CEV634-1A BIPOLAR INSERT CEV634-1A 350MM MOUIEL; LOT 130507; MFG 05/2013. (B)(4): PRODUCT ANALYSIS WAS PERFORMED ON PART# CEV669B. 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 # CEV6795B; NO ISSUES WERE FOUND. PRODUCT ANALYSIS WAS PERFORMED ON PART # CEV634-1A. PER THE ANALYSIS LOOSE DISTAL PLASTIC RING AND UNWELDED PROXIMAL METAL RING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLACK PLASTIC PIECE IS BURNT AT THE CONNECTION LEVEL. THERE WERE NO REPORTS OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483095 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 130502

    Patients

    Seq Age Sex Outcome Treatment
    1