BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI MULTIUSE HANDPIECE WITH FIBER ASSEMBLY

    MDR report key: 3090801 · Received May 2, 2013

    Report

    Report Number
    1419951-2013-00002
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K962632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE MANUFACTURER COMPLETED ALL OF THE INFORMATION ON THIS FORM. (B)(4).

    Description of Event or Problem · 1

    "SURGEON WAS USING ASSEMBLED FIBER/HANDPIECE, SCRUB TECH WAS SUPPORTING FIBER ON FIELD, FIBER BURNED A HOLE IN HER (SCRUB TECH'S) DOUBLED GLOVED LEFT HAND, AND LEFT A RED MARK ON HER HAND, WITH RESIDUAL BURNING AND TINGLING. THAT FIBER BLEW OUT THE SIDE ½ THE WAY DOWN THE FIBER." THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191361 OMNI MULTIUSE HANDPIECE WITH FIBER ASSEMBLY LASER FIBER GEX TRIMEDYNE, INC. 20471-HP 12D018

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR