BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3334800 VISAO 80K HANDPIECE

    MDR report key: 3213396 · Received July 9, 2013

    Report

    Report Number
    1045254-2013-00445
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). QUALITY ENGINEER PERFORMED ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE VISAO COULD NOT LOCK AND GOT HOT. DURING ANALYSIS, THE OVERHEATING CONDITION COULD NOT BE DUPLICATED, AS THE PRE-REPAIR TEMPERATURE CHECK COULD NOT BE CONDUCTED SINCE THE TEST BUR COULD NOT BE INSTALLED. IT WAS FOUND THAT THE CERAMIC BALL BEARINGS WHICH ARE A PART OF THE DEVICE¿S LOCKING MECHANISM WERE MISSING. IN ADDITION, THE BEARINGS WERE CORRODED. THE CERAMIC BALLS ARE LOCATED UNDERNEATH THE ROTATING LOCKING COLLAR OF THE VISAO AND ABOVE THE SHAFT ASSEMBLY, WHICH INCLUDES THE MIDDLE BEARINGS. THE CERAMIC BALLS ARE INACCESSIBLE WITHOUT DISASSEMBLY OF THE HANDPIECE. PER IPC IFU 68E4066 REV J, IF THE HANDPIECE IS ATTEMPTED TO BE RUN WITHOUT THE DRILL BEING IN THE LOCKED POSITION, IT IS EXPECTED THAT THE HANDPIECE MAY OVERHEAT. REFER TO FOLLOWING WARNINGS TAKEN FROM THE IFU. W36: SMOKE AND/OR EXCESSIVE HEAT MAY BE GENERATED IF ATTACHMENT IS NOT IN THE FULLY LOCKED POSITION. THIS MAY RESULT IN THERMAL INJURY TO THE SURGEON OR STAFF. W76: ALWAYS ENSURE THAT THE DRILL IS SECURELY ENGAGED INTO THE HANDPIECE PRIOR TO OPERATING THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL DOES NOT LOCK AND GETS HOT. THIS WAS DISCOVERED PREOPERATIVELY, AND THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312800 DRILL 3334800 VISAO 80K HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 206105509

    Patients

    Seq Age Sex Outcome Treatment
    1