BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 90876 · Received May 6, 1997

    Report

    Report Number
    2020601-1997-00036
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    November 6, 1996
    Report Date
    May 5, 1997
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT RECEIVED ON 5/9/97, TESTED PER THE ACCEPTANCE CRITERIA. INSTRUMENT OVERHEATED. TEAR DOWN OF INSTRUMENT SHOWED SPRING HAD CAUGHT ON RETAINER AND COILED AROUND SHAFT CAUSING FRICTION POINT. THIS PROBLEM HAS BEEN PREVIOUSLY INDENTIFIED AND HAS BEEN CORRECTED WITH REVISION TO THE COMPONENT AND ASSEMBLY INSTRUCTIONS. THE USER MANUAL OUTLINES MONITORING OF INSTRUMENT FOR OVERHEAT DURING USE AND COOLING INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CALL TO THE HOSPITAL TO RETRIEVE THE LOANER INSTRUMENT THAT THE DRILL ALLEGEDLY BURNED THE LOWER RIGHT LIP OF THE PT. NO DEGREE OF BURN WAS NOTED IN THE PT RECORD. THE PT WAS TREATED WITH SALINE RINSES. NO OTHER INTERVENTION OR ADDITIONAL PROCEDURE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE HIGH SPEED DRILL DZA MICROAIRE SURGICAL INSTRUMENTS, INC. 2910-100 4C418

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR