BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROCHOICE OSCILLATING SAW

    MDR report key: 826417 · Received March 6, 2007

    Report

    Report Number
    1017294-2007-00154
    Event Type
    Other
    Date Received
    March 6, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 7, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE OSCILLATING SAW WAS RETURNED FOR EVALUATION WITHOUT THE SAW BLADE. IT WAS REPORTED THAT THE SAW BLADE WAS DISCARDED BY THE FACILITY. DURING TESTING, THE HANDPIECE WAS FOUND TO MEET SPECIFICATIONS FOR OPERATING TEMPERATURE. FURTHER INVESTIGATION FOUND THIS HANDPIECE WAS MANUFACTURED 09/20/2004 AND HAS NO RECORD OF REPAIR AT CONMED LINVATEC. THE INSTRUCTION MANUAL INFORMS THE USER THAT CONMED LINVATEC RECOMMENDS ROUTINE MAINTENANCE EVERY 12 MONTHS FOR THIS HANDPIECE. FAILURE TO FOLLOW THIS ROUTINE MAINTENANCE SCHEDULE MAY RESULT IN DAMAGE TO THE HANDPIECE AND/OR INJURY TO THE PATIENT OR MEDICAL STAFF. THE CUSTOMER WILL BE PROVIDED ADDITIONAL INFORMATION ON THE CARE AND MAINTENANCE OF THIS HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS OSCILLATING, SAW IN A MANDIBULAR OSTEOTOMY, THE BLADE HEATED UP RESULTING IN REDNESS TO THE PATIENT'S LIP. IT WAS REPORTED THAT THERE WAS NO BREAK IN THE SKIN. THE REDNESS WAS TREATED WITH OINTMENT AND NO FURTHER TREATMENT IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROCHOICE OSCILLATING SAW OSCILLATING SAW HWE CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR UNKNOWN OSCILLATING BLADE