BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLORADO MICRONEEDLE

    MDR report key: 549634 · Received October 13, 2004

    Report

    Report Number
    549634
    Event Type
    Other
    Date Received
    October 13, 2004
    Date of Event
    October 4, 2004
    Report Date
    October 11, 2004
    Manufacturer
    STRYKER LEIBINGER, INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ELECTROSURGICAL PROCEDURE A MICRO DISSECTION NEEDLE WAS USED IN A VALLEYLAB HANDPIECE. AFTER M.D., MEDICAL DOCTOR, FINISHED USING THE NEEDLE AND HAD THE HANDPIECE IN HAND, THE MICRONEEDLE STARTED ON FIRE. A FLAME MELTED THE INSULATION ON THE MICRONEEDLE. AT THE TIME OF THE FLAME, THE MICRONEEDLE WAS NOT IN CONTACT WITH THE PATIENT OR STAFF AND SO NO INJURY RESULTED. IN FOLLOW UP, IT WAS REPORTED THAT THE MICRONEEDLE WAS USED AT EXCESSIVELY HIGH (20+) WATTS AND THE MANUFACTURER RECOMMENDS THAT IT IS EFFECTIVE AT LOW POWER SETTINGS (3-5 WATTS). STAFF INFORMED THAT MICRONEEDLE IS NOT TO BE USED AT HIGH WATTAGE AND IT WILL BE REMOVED FROM VARIOUS SURGEONS' SURGICAL SUPPLY REQUISITION FORMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO MICRONEEDLE ELECTROSURGICAL MICRO DISSECTION NEEDLE GEI STRYKER LEIBINGER, INC. * 04084327

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR