BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV605G 3PK 350MM [MXI/XOM]

    MDR report key: 3290618 · Received August 15, 2013

    Report

    Report Number
    9680837-2013-00022
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 21, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CEV605G (LOT # 120202, QUANTITY 4) -MANUFACTURE DATE: FEBRUARY 2012; CEV605G (LOT # 120201, QUANTITY 3) -MANUFACTURE DATE: FEBRUARY 2012; CEV605G (LOT # 120902, QUANTITY 1) - MANUFACTURE DATE: SEPTEMBER 2012. (B)(4). RESULT CODE: STRESS PROBLEM. NINE INSTRUMENTS (PART # CEV605G) WERE RETURNED TO MXI SERVICE <(>&<)> REPAIR. EVALUATION INDICATED THAT THE ALL THE RETURN DEVICES HAS DAMAGE ON THE BLACK PLASTIC SKIRTS. THE DEGREE OF DAMAGE ON EACH INSTRUMENT IS DIFFERENT. THE BLADES ON EACH DEVICE ARE BLUNT AND REQUIRE SHARPENING. THE DAMAGE DETECTED ON THE PLASTIC SKIRTS IS MOST LIKELY DUE TO ABNORMAL USE OR AN EXCESSIVE STRAIN OF THE SCISSORS WHEN REMOVING FROM TROCARS. 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. (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. (B)(4).

    Description of Event or Problem · 1

    NINE INSTRUMENTS (PART # CEV605G) WERE RETURNED TO MXI SERVICE <(>&<)> REPAIR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394239 SCISSORS INSERT CEV605G 3PK 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S CEV605G 120202

    Patients

    Seq Age Sex Outcome Treatment
    1