BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV607 6PK DIA 5MM

    MDR report key: 3338747 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00289
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    October 31, 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

    THE DEVICES WERE EVALUATED AND INDICATED THAT THE BLADES WERE BLUNT. THE PLASTIC SKIRT WAS DAMAGED. THE BLADES WERE BLUNT RESULTING FROM INSTRUMENT USE. SHARPENING WAS NECESSARY. THE BLACK PLASTIC SKIRT WAS PROBABLY DAMAGED AFTER WITHDRAWAL FROM THE TROCAR. (B)(6). 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

    TWO DEVICES (PART#: CEV607, LOT: 120504) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428117 SCISSORS INSERT CEV607 6PK DIA 5MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV607 120504

    Patients

    Seq Age Sex Outcome Treatment
    1