BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS CEV104M DIA 5MM 350MM STR

    MDR report key: 3338233 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00263
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 5, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON
    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: CEV104M (LOT: 111101) - MFG DATE: 11/2011. (B)(6). CEV104M (LOT: 199811MF): EVAL OF THIS INSTRUMENT INDICATED THAT THE SHEATHING PRESENTED WITH TRACES OF IMPACT. CEV104M (LOT: 111101): EVAL OF THIS INSTRUMENT INDICATED THAT THE SCISSORS WERE NOT CUTTING EFFECTIVELY, WAS MOST LIKELY DUE TO NORMAL WEARING. THE SCISSORS NEEDED TO BE SHARPENED. 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.

    Description of Event or Problem · 1

    TWO DEVICES (CEV104M) WERE RETURNED TO MXI SVC AND REPAIR TO ADDRESS A WARRANTY REPAIR REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425989 SCISSORS CEV104M DIA 5MM 350MM STR GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV104M 199811MF

    Patients

    Seq Age Sex Outcome Treatment
    1