BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI-LINE / HI-LINE XS HANDPIECES

    MDR report key: 722696 · Received May 31, 2006

    Report

    Report Number
    2916714-2006-00036
    Event Type
    Other
    Date Received
    May 31, 2006
    Date of Event
    May 8, 2006
    Report Date
    May 30, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    HBB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO DIFFERENT LUMBAR DISECTOMY PROCEDURES, SAME SURGEON. BOTH MOTORS AND/OR HANDPIECES HEATED UP AND ONE HEATED UP SO MUCH THAT IT BURNED THE SURGEON'S INNER ASPECT ON INDEX FINGER DURING THE SECOND PROCEDURE. NO PROLONGING OF SURGERY OR PT INCIDENT FOR EITHER CASE. NOT SURE WHICH SET WAS USED DURING PROCEDURE WHEN SURGEON WAS BURNED. SURGEON WAS DOUBLE GLOVED. HE HAD TO BE TREATED FOR IST DEGREE BURN (SILVADANE OINTMENT TO TREAT BURN) REFERENCE: 2916714-2006-00035 DEVICE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LINE / HI-LINE XS HANDPIECES MOTOR, DRILL, PNEUMATIC HBB AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN