BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669E DIA 5MM ERG BIPOLAR

    MDR report key: 3338569 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00392
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    February 14, 2012
    Report Date
    February 25, 2013
    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

    TWO OF THREE DEVICE: CEV647B5 (LOT: 120102) - MFG DATE: 01/2012; THREE OF THREE DEVICE: CEV625H (LOT: 120304) - MFG DATE: 03/2012. (B)(6). EVAL OF THIS INSTRUMENT INDICATED THAT THE BLACK PLASTIC PIECE WAS BURNT AT THE CONNECTION LEVEL AND THE HANDLE WAS SIGNIFICANTLY BENT. THE BURNT PLASTIC WAS MOST LIKELY DUE TO THE FORMATION OF AN ELECTRIC ARC, WHICH WAS MOST LIKELY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED, BLOOD, TISSUES). THE INSTRUMENT MOST LIKELY ALSO SUFFERED EXCESSIVE EFFORT AT THE HANDLE LEVEL. CEV647B: EVAL OF THIS INSTRUMENT INDICATED THAT THE SHEATH WAS DAMAGED AND PRESENTED WITH TRACES OF IMPACT. THE DAMAGE WAS MOST LIKELY A RESULT OF IMPACT OR ABRASIONS DURING THE USE OR THE REPROCESSING. CEV625H: EVAL OF THIS INSTRUMENT INDICATED THAT THE INSERT COATING WAS DAMAGED AT THE BACK OF THE JAWS AND ALONGSIDE THE STRING. THE COATING WAS MOST LIKELY DAMAGED BY IMPACT DURING THE USE OR THE REPROCESSING. IT WAS RECOMMENDED THAT THE CLIENT USE THE PROTECTION PROVIDED. 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. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (CEV669E, CEV647B5, AND CEV625H) WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427598 HANDLE CEV669E DIA 5MM ERG BIPOLAR GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV669E 120305

    Patients

    Seq Age Sex Outcome Treatment
    1