BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCHOICE BUR GUARD, MEDIUM

    MDR report key: 1213708 · Received October 21, 2008

    Report

    Report Number
    1017294-2008-00316
    Event Type
    Other
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    EQJ
    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 BUR GUARD FOR EVALUATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. DURING TESTING OF THIS BUR GUARD, IT MET MANUFACTURER TEMPERATURE SPECIFICATIONS. FURTHER INVESTIGATION FOUND THE BUR GUARD OVERDUE FOR PREVENTATIVE MAINTENANCE; LAST REPAIR DATE FOUND IS (B) (6) 2007. ASSOCIATED REPORT: 1017294-2008-00315. THE INFORMATION FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION FOR THE USER REGARDING THIS DEVICE: WARNINGS: PRIOR TO EACH USE, ALL EQUIPMENT MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IF BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. IF OVERHEATING OCCURS, DISCONTINUE USE AND RETURN FOR SERVICE. GUARDS ARE TO BE RETURNED TO LINVATEC/HALL SURGICAL EVERY SIX MONTHS FOR ROUTINE MAINTENANCE. BUR GUARD TEST PROCEDURE: PRIOR TO ATTACHING THE BUR GUARD; CHECK FOR WORN BEARINGS BY INSERTING A BUR INTO THE NOSE OF THE BUR GUARD. WHILE HOLDING THE BUR, SPIN THE GUARD. THE GUARD SHOULD SPIN FREELY AROUND THE BUR SHAFT WITHOUT RESTRICTIONS. ATTACH THE BUR AND GUARD TO THE DRILL USING THE FOLLOWING INSTRUCTIONS. RUN THE INSTRUMENT FOR AT LEAST 30 SECONDS, CAREFULLY FEELING THE TIP OF THE GUARD FOR HEAT. IF HEAT IS NOTICED, DISCONTINUE USE AND RETURN TO LINVATEC/HALL SURGICAL FOR SERVICE. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFORMATION ON THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS BUR GUARD 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 FOR 20 MINUTES, AND ANOTHER DEVICE 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 BUR GUARD, MEDIUM BUR GUARD EQJ CONMED LINVATEC NA OCT07S

    Patients

    Seq Age Sex Outcome Treatment
    1 NK MICROCHOICE ELITE HIGH SPEED DRILL,| CATALOG #: 00502002500 AND (B) (4)