BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CP390-2 MONOPOLAR 160MM STR

    MDR report key: 3338732 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00290
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 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 5: CP390-2 (LOT: 03/12) - MFG DATE: 03/2012, DEVICE 3 OF 5: CP390-2 (LOT: 03/12) - MFG DATE: 03/2012, DEVICE 4 OF 5: C9390-3 (LOT: 04/12) - MFG DATE: 04/2012, DEVICE 5 OF 5: CP390-3 (LOT: 03/12) - MFG DATE: 03/2012. (B)(6). EVAL OF ALL FIVE DEVICES INDICATED THAT THE COATING WAS DAMAGED ON THE FORCEPS JAW. THE COATING WAS MOST LIKELY DAMAGED AS A RESULT OF EXCESSIVE RUBBING AGAINST AN ABRASIVE SURFACE. THIS ABRASION CREATED A HOLE IN THE COATING AND AN ELECTRICAL ISOLATION FAULT. 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

    FIVE DEVICES (PART#: CP390-2 AND CP390-3) WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427568 FORCEPS CP390-2 MONOPOLAR 160MM STR GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CP390-2 03/12

    Patients

    Seq Age Sex Outcome Treatment
    1