BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3346674 · Received September 13, 2013

    Report

    Report Number
    1045254-2013-00514
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 12, 2013
    Report Date
    August 21, 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: TUBE DIAM 5MM 350MM; MODEL # CEV6795B; LOT # 130304; MFG 3/27/2013. BIPOLAR INSERT 350MM MOUIEL; MODEL #CEV631-1A; LOT # 130507; MFG 5/23/2013. CABLE 4.5M BIPOLAR ERBE; MODEL # CP393-3; LOT # NOT PROVIDED; MFG UNKNOWN. (B)(4): THE RETURNED HANDLE WAS ANALYZED BY QUALITY ENGINEER. 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). NO ISSUES OR NONCONFORMANCES WERE IDENTIFIED FOR THE RETURNED TUBE. FOR THE BIPOLAR INSERT, THE ELECTRODE IS ON SHORT CIRCUIT. WE DID NOT HIGHLIGHT ANY SURFACE DEFECTS. THE SHORT CIRCUIT IS PROBABLY THE CONSEQUENCE OF THE ELECTRICAL INCIDENT ON THE HANDLE AND CABLE. THE CABLE CONNECTION AREA IS BURNT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE END OF A PAIR OF BIPOLAR PLIERS AND CABLE/ BAD CONTACT AT THE CONNECTION BETWEEN THE CABLE AND THE PLIERS WERE BURNED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460777 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 110702

    Patients

    Seq Age Sex Outcome Treatment
    1