BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CEV134 BIPOLAR 350MM MOUIEL

    MDR report key: 3338748 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00288
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2: CEV134 (LOT#111002) - MFG DATE: OCTOBER 2011. CEV134-LOT#120701 WAS EVALUATED AND INDICATED THAT THE ELECTRODE COATING WAS HEAVILY DAMAGED. THE PLASTIC PART IS CARBONIZED. THE COATING WAS PROBABLY DAMAGED BY EXCESSIVE ABRASION PROBABLY DURING THE REPROCESSING STAGES. THE PLASTIC COMBUSTION WAS DUE TO THE FORMATION OF AN ELECTRIC ARC PROBABLY FOLLOWING THE ABNORMAL PRESENCE OF LIQUID OR TISSUE ON THE PINS. CEV134-LOT#111002 WAS EVALUATED AND INDICATED THAT THE COATING WAS HEAVILY DAMAGED. THE FORCEPS WAS IN SHORT CIRCUIT. THE COATING WAS DAMAGED BY EXCESSIVE ABRASION PROBABLY DURING THE REPROCESSING STAGES. (B)(6). NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. MEDTRONIC'S REFERENCE #: N/A. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (PART#CEV134) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425290 FORCEPS CEV134 BIPOLAR 350MM MOUIEL GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV134 120701

    Patients

    Seq Age Sex Outcome Treatment
    1