BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCHOICE BUR GUARD, MEDIUM

    MDR report key: 1644431 · Received March 26, 2010

    Report

    Report Number
    1017294-2010-00043
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 2, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    EJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE RETURNED BUR GUARD DID NOT CONFIRM OVERHEATING. DURING TESTING, THE BUR GUARD MET MANUFACTURE TEMPERATURE SPECS AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS, FURTHER INSPECTION FOUND THE O-RING WORN. IN ADDITION, SERVICE RECORDS INDICATED THAT THIS UNIT IS OVERDUE FOR SERVICE; LAST REPAIR 09/2006. AN EVAL OF THE HANDPIECE USED WITH THIS BUR GUARD FOUND THAT THE UNIT MET MANUFACTURE TEMPERATURE SPEC AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS. LAST SERVICE DATE FOR THIS HANDPIECE WAS (B) (6) 2010. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER: PRIOR TO EACH USE, ALL INSTRUMENTS & ACCESSORIES MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IN THE INSTRUMENT OR ACCESSORY BEARINGS ARE WORN OR NOT KEPT CLEANED. CONTINUALLY CHECK ALL PARTS OF THE INSTRUMENT OR ITS ATTACHMENTS FOR OVERHEATING. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE. IN ADDITION, OVERHEATING MAY OCCUR IF THE BEARING IN THE TIP OF THE BUR GUARD IS WORN, POSSIBLY CAUSING SERIOUS BURN TO THE PT'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. AS CERTAIN INTERNAL COMPONENTS (BEARINGS) ARE KNOWN TO DEGRADE OVERTIME, CONMED LINVATEC RECOMMENDS A SERVICE INTERVAL FOR THIS HANDPIECE AND ITS ASSOCIATED BUR GUARDS EVERY 6 MONTHS. FAILURE TO FOLLOW THIS SERVICE SCHEDULE MAY RESULT IN OVERHEATING OR DAMAGE TO THE HANDPIECE AND/OR BUR GUARD, AND MAY RESULT IN BURN INJURY TO THE PT OR MEDICAL PERSONNEL.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING USE OF THIS BUR GUARD TO PERFORM A THIRD MOLAR EXTRACTION, IT BECAME HOT AND THE PT RECEIVED A BLISTER TO THE LIP. FOLLOWING THE SURGEON OBTAINED ANOTHER BUR GUARD AND HANDPIECE FOR USE, AND THE SURGERY WAS COMPLETED AS INTENDED. THE USER APPLIED HYDROCORTISONE OINTMENT TO THE BLISTER WHICH HE DESCRIBED AS SUPERFICIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE BUR GUARD, MEDIUM SURGICAL INSTRUMENT MOTOR ACCESS/ATTACH EJL CONMED LINVATEC 00447295

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other MICROCHOICE HIGH SPEED DRILL| CATALOG #: 00502002500 & (B) (4)