BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCHOICE ELITE HIGH SPEED DRILL

    MDR report key: 1213704 · Received October 21, 2008

    Report

    Report Number
    1017294-2008-00315
    Event Type
    Other
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    DZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE HANDPIECE FOR EVALUATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. DURING TESTING OF THIS HANDPIECE, IT FUNCTIONED TO MANUFACTURER TEMPERATURE SPECIFICATION. FURTHER INVESTIGATION FOUND A CRACKED COLLET SLEEVE, AND THE CAUSE OF THIS FAILURE WAS UNABLE TO BE DETERMINED. ASSOCIATED REPORT: 1017294-2008-00316. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER OF THE FOLLOWING: PRIOR TO EACH USE, THE MICROCHOICE ELITE HIGH SPEED DRILL AND ALL ASSOCIATED EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. ENSURE ALL ATTACHMENTS AND 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 PT OR MEDICAL PERSONNEL. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS HANDPIECE TO PERFORM A THIRD MOLAR EXTRACTION, IT GOT HOT RESULTING IN A BURN TO THE PT'S LEFT LOWER LIP. THE SURGEON REPORTED THAT THE PROCEDURE WAS DELAYED ABOUT 20 MINUTES, AND ANOTHER HANDPIECE WAS OBTAINED TO COMPLETE THE SURGICAL PROCEDURE. THE PT'S LIP WAS TREATED WITH VASELINE AND NO OTHER INTERVENTION WAS REQUIRED.

    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 Other CATALOG #: 0050200600| MICROCHOICE MEDIUM BUR GUARD