BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCHOICE ELITE HIGH SPEED DRILL

    MDR report key: 1587325 · Received January 12, 2010

    Report

    Report Number
    1017294-2010-00007
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 24, 2009
    Manufacturer
    CONMED LINVATEC
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM OF OVERHEATING. DURING TESTING, THIS UNIT OVERHEATED AND THEN CEASED TO FUNCTION. FURTHER EVALUATION FOUND MOTOR FAILURE WITH WORN ROTOR BEARINGS. THE HANDPIECE INSTRUCTION MANUAL PROVIDES THE FOLLOWING INFO: PRIOR TO USE/TESTING, 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. BUR GUARDS IS EVERY 6 MONTHS. THE CUSTOMER WILL BE PROVIDED ADDITIONAL INFO ON CARE AND HANDLING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IN THE BEGINNING OF AN ORAL SURGICAL PROCEDURE, THIS DRILL GOT HOT. THE USER FELT THE HEAT IN THE BODY OF THE HANDPIECE AND DISCONTINUED USE. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.

    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