BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV605-1 350MM DIA 5MM

    MDR report key: 3337837 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00394
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 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

    DEVICE 2 OF 3: CEV649-5B (LOT# 121207) - MANUFACTURING DATE: DECEMBER 2012. DEVICE 3 OF 3: CEV10395D (LOT# 121201) - MANUFACTURING DATE: DECEMBER 2012. THE DEVICE (PART#CEV605-1) WAS EVALUATED AND INDICATED THAT THE INSERT WAS VERY SHARPLY BENT AND JAMMED IN THE TUBE. ONE OF THE BLADES WAS BROKEN. THE INSERT WAS ALMOST CERTAINLY SUBJECTED TO EXTREMELY EXCESSIVE FORCE. THE CEV659-5B WAS EVALUATED AND INDICATED THAT THE TUBE AND INSERT WERE VERY SHARPLY BENT. THE INSTRUMENTS WERE SUBJECTED TO EXTREMELY EXCESS FORCE. THE CEV10395D WAS EVALUATED AND NO PROBLEMS WERE OBSERVED. INSTRUMENT WAS COMPLAINT WITH MANUFACTURING SPECIFICATIONS. (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 IN 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 INTERNAL REFERENCE #: NA. (B)(4).

    Description of Event or Problem · 1

    THREE DEVICES (PART#CEV605-1, CEV649-5B, AND CEV10395D) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424927 SCISSORS INSERT CEV605-1 350MM DIA 5MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV605-1 121201

    Patients

    Seq Age Sex Outcome Treatment
    1