BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV607 6PK DIA 5MM

    MDR report key: 3338678 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00317
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 5, 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

    COMPLAINANT/FACILITY: (B)(6). EV607 (LOT: 111201): EVALUATION OF THIS DEVICE INDICATED THAT THE BLADES WERE BLUNT AND THE PEEK SKIRTS WERE DAMAGED. THE BLADES NEEDED TO BE SHARPENED AND THE PLASTIC SKIRTS WERE MOST LIKELY DAMAGED AFTER IMPACT. CEV607 (LOT: 120402): EVALUATION OF THIS DEVICE INDICATED THAT THE BLADES WERE BLUNT AND THE PLASTIC SKIRTS WERE DAMAGED. THE BLADES NEEDED TO BE SHARPENED AND THE PLASTIC SKIRTS WERE MOST LIKELY DAMAGED AFTER IMPACT. CEV10395R: NO PROBLEMS WERE OBSERVED. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC¿S MXI FACILITY IN (B)(6). 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 [CEV607 (QTY 2) AND CEV10395R] WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424755 SCISSORS INSERT CEV607 6PK DIA 5MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV607 111201

    Patients

    Seq Age Sex Outcome Treatment
    1