BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CEV134 BIPOLAR 350MM MOUIEL

    MDR report key: 3338752 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00285
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 7, 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 3: CEV134 (LOT#09/03) - MFG DATE: 09/2003. DEVICE 3 OF 3: CEV134 (LOT#05/06) - MFG DATE: 05/2006. THE DEVICE (PART#CEV134-LOT#120702) WAS EVALUATED AND INDICATED THAT THE BLACK PLASTIC PART WAS CARBONIZED, WHICH CREATES A SHORT CIRCUIT. THE PLASTIC COMBUSTION WAS THE RESULT OF THE FORMATION OF AN ELECTRIC ARC. THE ORIGIN IS VERY LIKELY DUE TO THE PRESENCE OF HUMIDITY OR RESIDUE THAT COULD BE DUE TO INSUFFICIENT DRYING OR CLEANING OF THE INSTRUMENT OR CABLE. IN ADDITION, THE INCIDENT WAS REPEATED ON SEVERAL DIFFERENT INSTRUMENTS, A CABLE MALFUNCTION COULD ALSO BE THE CAUSE. CEV134-LOT#09/03 WAS EVALUATED AND INDICATED THAT THE TUBE WAS BROKEN. THE ELECTRODE COATING WAS EXTREMELY DAMAGED. THE INSTRUMENT WAS IN SHORT CIRCUIT. THE CAUSE WAS LIKELY AN EXCESSIVE FORCE AND ABNORMAL ABRASION ON THE ELECTRODE COATING. CEV134-LOT#05/06 WAS EVALUATED AND INDICATED THAT THE INSTRUMENT PRESENTS MARKINGS NOT AFFIXED BY MICROFRANCE. (B)(4). THE PLASTIC SPACER BETWEEN THE CONNECTION PINS WAS DAMAGED AND DOES NOT SEEM TO BE THE ORIGINAL. THE SUPERIOR PIN WAS ALSO MODIFIED. THE INSTRUMENT WAS PROBABLY REPAIRED BY AN UNQUALIFIED MEDTRONIC SERVICE PROVIDER. THE INSTRUMENT WAS DECLARED UNREPAIRABLE. (B)(6). EVAL OF CEV525 INDICATED THE SHEATH WAS EXTREMELY DAMAGED AND CUT. THE INSTRUMENT WAS MOST LIKELY SUBJECTED TO ABNORMAL USE. THE SHEATH WAS MOST LIKELY DAMAGED WHEN BEING REMOVED FROM THE TROCAR OR WITH A CUTTING INSTRUMENT. 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 (PART#CEV134) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425488 FORCEPS CEV134 BIPOLAR 350MM MOUIEL GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV134 120702

    Patients

    Seq Age Sex Outcome Treatment
    1