BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCHOICE ELITE HIGH SPEED DRILL

    MDR report key: 1589420 · Received January 8, 2010

    Report

    Report Number
    1017294-2010-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 13, 2009
    Report Date
    December 24, 2009
    Manufacturer
    CONMED LINVATEC
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS DRILL FOR EVALUATION & CONFIRMED THE REPORTED PROBLEM OF OVERHEATING. DURING TESTING, THE UNIT EXCEEDED MANUFACTURER TEMPERATURE SPECIFICATION IN THE COLLET RELATED TO A WORN COLLET/BEARING ASSEMBLY. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER OF THE FOLLOWING: PRIOR TO EACH USE, THIS DRILL & ALL ASSOCIATED EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. ENSURE ALL ATTACHMENTS & ACCESSORIES ARE CORRECTLY ATTACHED TO THE HANDPIECE. PERFORMANCE TEST PRIOR TO USE: OPERATE THE DRILL AT MAXIMUM SPEED (100,000 RPM) FOR ONE MINUTE AND MONITOR FOR ANY OF THE FOLLOWING: EXCESSIVE NOISE. EXCESSIVE VIBRATION. THE DRILL OR BUR GUARD BEING HOT TO THE TOUCH DURING THE TEST PROCEDURE OR DURING SURGICAL USE. WARNING: USE OF A DRILL NOT FUNCTIONING PROPERLY CAN RESULT IN INJURY TO THE PATIENT OR MEDICAL PERSONNEL. OVERHEATING MIGHT OCCUR IF THE HANDPIECE OR ACCESSORY BEARINGS ARE WORN OR NOT KEPT CLEAN. CONTINUALLY CHECK ALL PARTS OF THE HANDPIECE & ATTACHMENTS FOR OVERHEATING. DISCONTINUE USE & RETURN THE EQUIPMENT FOR SERVICE AS NECESSARY. OVERHEATING CAN CAUSE SERIOUS INJURY TO THE PATIENT OR OPERATING ROOM PERSONNEL. IN ADDITION, OVERHEATING MAY OCCUR IF THE BEARING IN THE TIP OF THE BUR GUARD IS WORN, POSSIBLY CAUSING SERIOUS BURN TO THE PATIENT'S TISSUE. TO REDUCE THE RISK OF INJURY, PRIOR TO SURGERY, SPIN THE BUR GUARD ON A BUR. IF THE BUR GUARD SPINS FREELY, THE BEARING IS STILL GOOD. OTHERWISE, THE BUR GUARD SHOULD BE SENT FOR REPAIR IMMEDIATELY. DO NOT USE. THE SERVICE INTERVAL FOR THIS DRILL & BUR GUARD IS EVERY SIX MONTHS. THE CUSTOMER WILL BE PROVIDED ADDITIONAL EDUCATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS DRILL IN ORAL SURGERY, IT MADE A STRANGE NOISE AND STARTED HEATING UP. THE USER WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS HANDPIECE WITHOUT INJURY TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE ELITE HIGH SPEED DRILL ARTHROSCOPE, ORTHOPEDIC EJL CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1