BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON FIBER WITH FLAT TIP

    MDR report key: 2223782 · Received August 25, 2011

    Report

    Report Number
    1419951-2011-00013
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K973172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE MANUFACTURER COMPLETED ALL OF THE INFORMATION ON THIS FORM. (B)(4). NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4). MATERIAL SEPARATION; BURN OF DEVICE OR DEVICE COMPONENT; MELTED; CHARRED. NOTE: THIS EVENT WAS INITIALLY DETERMINED TO NOT BE REPORTABLE BASED ON INITIAL REPORT . HOWEVER, THE INITIAL EVALUATION OF THE RETURNED DEVICE ON (B)(4) 2011 LED TO THE DECISION TO REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FIBER WAS IN THE STERILE FIELD AND THEY ATTEMPTED TO USE IT, BUT WHEN IN THE PATIENT, IT DID NOT FUNCTION. THEY DID NOT SEE THE AIMING BEAM, AND THERE WAS NO POWER TO THE FIBER. OUT OF THE PATIENT, THE FIBER DID NOTHING WHEN DIRECTED AT THE TEST AREA OF THE LASER UNIT. NO PATIENT ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 200 MICRON FIBER WITH FLAT TIP LASER FIBER GEX TRIMEDYNE, INC. B200 10E035

    Patients

    Seq Age Sex Outcome Treatment
    1