BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGAIRTOME TWO HANDPIECE

    MDR report key: 1062971 · Received June 16, 2008

    Report

    Report Number
    1017294-2008-00231
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVALUATION, AND CONFIRMED OVERHEATING. IN ADDITION, THE EVALUATOR NOTED THAT THE HANDPIECE OPERATED NOISY AND THE MOTOR RAN INTERMITTENTLY. FURTHER INVESTIGATION FOUND EVIDENCE OF THIRD PARTY REPAIR. THE INSTRUCTION MANUAL FOR THIS HANDPIECE INFORMS THE USER OF THE FOLLOWING: PRIOR TO EACH USE, ALL INSTRUMENTS AND ACCESSORIES MUST BE INSPECTED FOR PROPER OPERATION. OVERHEATING MIGHT OCCUR IF THE INSTRUMENT OR ACCESSORY BEARINGS ARE WORN OR ARE NOT KEPT CLEANED. CONTINUALLY CHECK ALL PARTS OF THE INSTRUMENT OR ITS ATTACHMENTS FOR OVERHEATING AND DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE AS NECESSARY. OVERHEATING CAN CAUSE SERIOUS INJURY TO THE PATIENT OR OPERATING ROOM PERSONNEL. OVERHEATING MAY OCCUR IF THE BEARING IN THE TIP OF THE BUR GUARD IS WORN, POSSIBLY CAUSING SERIOUS BURNING OF 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 MUST BE SENT FOR REPAIR IMMEDIATELY. DO NOT USE. THE USER IS INFORMED THAT THE RECOMMENDED SERVICE INTERVAL FOR THIS DRILL IS EVERY 12 MONTHS, AND FOR ITS ASSOCIATED BUR GUARDS EVERY 6 MONTHS. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFORMATION REGARDING THIS PRODUCT. ASSOCIATED MDRS: 1017294-2008-00232, 1017294-2008-00234.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS HANDPIECE IT BECAME HOT. THE USER FELT THE HEAT AT "THE END OF THE HANDPIECE" AND DISCONTINUED USE. THE CUSTOMER REPORTED THAT AN ALTERNATE HANDPIECE WAS USED TO COMPLETE THE SURGERY AS INTENDED WITHOUT SERIOUS INJURY OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGAIRTOME TWO HANDPIECE HIGH SPEED DRILL GET CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK MEDIUM BUR GUARD| & LOT#: FEB00 OR SEP88