BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV605G 3PK 350MM

    MDR report key: 3338630 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00355
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 2, 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

    (B)(6). DEVICE 1 OF 7, CEV605G, LOT 120201, QTY1: EVAL OF THIS INSTRUMENT INDICATED THAT THE BLADES WERE BLUNT AND THE BLACK PLASTIC SKIRT WAS DAMAGED. DEVICES 2-7 OF 7, CEV605G, LOT 120202, QTY6: MANUFACTURING DATE 02/2012, EVAL OF THESE INSTRUMENTS INDICATED THAT THE BLADES WERE BLUNT, WHICH WAS MOST LIKELY DUE TO USE OF THE INSTRUMENT. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINT 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 REF #: NA. (B)(4).

    Description of Event or Problem · 1

    SEVEN DEVICES (CEV605G) WERE RETURNED FOR REPAIR AND SHARPENEING TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427278 SCISSORS INSERT CEV605G 3PK 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV605G 120201

    Patients

    Seq Age Sex Outcome Treatment
    1