BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV605G 3PK 350MM

    MDR report key: 3338744 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00295
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 16, 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 OF 2: CEV605G: LOT #111104, MANUFACTURING DATE: 11/2011. CEV605G (LOT NUMBER 120702) WAS EVALUATED AND INDICATED THAT THE BLADES WERE BLUNT. THE SHEATH PRESENTS TRACES OF COLLISION. THE INSERT PRESENTS A SLIGHT RUBBING AT INSERTION. THE BLADES NEED TO BE SHARPENED. THE SHEATH WAS VERY LIKELY DAMAGED DURING DISASSEMBLY WITH FORCEPS. CEV605G (LOT NUMBER 111104) WAS EVALUATED AND INDICATED THAT THE BLADES ARE BLUNT. THE SHEATH PRESENTS TRACES OF COLLISION. THE BLADES NEED TO BE SHARPENED. THE SHEATH WAS VERY LIKELY DAMAGED AFTER AN ATTEMPT TO DISASSEMBLE WITH FORCEPS. (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. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (PART NUMBER CEV605G) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427569 SCISSORS INSERT CEV605G 3PK 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON CEV605G 120702

    Patients

    Seq Age Sex Outcome Treatment
    1