BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCHOICE ELITE HIGH SPEED DRILL

    MDR report key: 1025908 · Received April 2, 2008

    Report

    Report Number
    1017294-2008-00173
    Event Type
    Other
    Date Received
    April 2, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED LINVATEC RECEIVED THE HANDPIECE FOR EVALUATION AND WAS UNABLE TO CONFIRM THE REPORTED PROBLEM AS THE HANDPIECE MET MANUFACTURER TEMPERATURE SPECIFICATIONS. THE CONCOMITANT BUR GUARD WAS NOT RETURNED FOR EVALUATION. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER OF THE FOLLOWING: OVERHEATING MIGHT OCCUR IF THE HANDPIECE OR ACCESSORY BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. CONTINUALLY CHECK ALL PARTS OF THE HANDPIECE AND ATTACHMENTS FOR OVERHEATING. DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE AS NECESSARY. OVERHEATING CAN CAUSE SERIOUS INJURY TO THE PT OR OPERATING ROOM PERSONNEL. THE RECOMMENDED SERVICE INTERVAL FOR THIS DRILL AND ASSOCIATED BUR GUARDS IS EVERY 6 MONTHS. WARNING: FAILURE TO FOLLOW THE SERVICE SCHEDULE COULD RESULT IN REDUCED INSTRUMENT PERFORMANCE OR OVERHEATING OF THE DRILL OR GUARD. IN ADDITION, HEAVY USE OF THE DRILL EXCEEDING THE DUTY CYCLE CAN CAUSE THE HANDPIECE TO OVERHEAT. OVERHEATING CAN LEAD TO POSSIBLE BURN OR INJURY TO THE PT OR MEDICAL PERSONNEL. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFO REGARDING THIS PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BILATERAL SAGITTAL SPLIT MANDIBULAR OSTEOTOMY (BSSO) THE HANDPIECE BECAME HOT AND RESULTED IN A PT BURN TO THE LOWER LIP. A COUPLE OF SUTURES WERE REQUIRED AND OINTMENT WAS APPLIED TO THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE ELITE HIGH SPEED DRILL DRILL DZI CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Required Intervention MICROCHOICE BUR GUARD, CATALOG & LOT #UNK