BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI(TM) MULTIUSE HANDPIECE

    MDR report key: 2193283 · Received August 5, 2011

    Report

    Report Number
    1419951-2011-00009
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 20, 2010
    Report Date
    August 25, 2011
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K962632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NOTE: THE MANUFACTURER COMPLETED ALL OF THE INFORMATION ON THIS FORM. (B)(4) - BURN OF DEVICE OR DEVICE COMPONENT. (B)(4) - CORROSION. (B)(4) - CHARRED. (B)(4) - MELTED. (B)(4) - RESIDUE AFTER DECONTAMINATION. (B)(4) - OVERHEATING OF DEVICE OR DEVICE COMPONENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A KNEE ARTHROSCOPY PROCEDURE, THE TIP WAS REMOVED FROM THE KNEE AND THE HANDPIECE WAS OBSERVED TO BE ON FIRE. THE LASER WAS PLACED INTO STANDBY MODE, AND THE FIBER WAS UNPLUGGED BY THE LASER TECHNICIAN WHILE "THE SCRUB TECH USED A WET RAYTECH AND WRAPPED IT AROUND THE HANDPIECE AND PUT OUT THE FLAME." THE LASER WAS SET TO 2.0 JOULES AT A RATE OF 40 PPS, WHICH GIVES 80 WATTS. THE TOTAL ENERGY USED WAS 61.20 KJ (NOTE THAT THIS WAS MISTAKENLY REPORTED TO TRIMEDYNE AS 61.20 J). A SINGLE-USE TIP AND A REUSABLE HANDPIECE/FIBER ASSEMBLY WERE BEING USED, BUT THE REPORTER DID NOT REPORT HOW MANY TIMES EITHER COMPONENT HAD BEEN USED. THERE WAS NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI(TM) MULTIUSE HANDPIECE LASER FIBER GEX TRIMEDYNE, INC. 20471-HP 905024

    Patients

    Seq Age Sex Outcome Treatment
    1