BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEC BARE HOLMIUM FIBERS

    MDR report key: 3173788 · Received June 17, 2013

    Report

    Report Number
    1419951-2013-00003
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    June 17, 2013
    Manufacturer
    TRIMEDYNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE ALLEGED MANUFACTURER COMPLETED ALL OF THE INFORMATION ON THIS FORM. ADDITIONAL INFORMATION: ACTUAL MFR. OF THE DEVICE: FORTEC COMPANIES, ADDRESS: (B)(4). (B)(4). EVALUATION, METHOD: DEVICE NOT RETURNED--EVALUATION BASED ON REPORTER'S NARRATIVE AND ADDITIONAL INFORMATION SUBSEQUENTLY OBTAINED FROM REPORTER, AND ACTUAL MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERGOING RIGHT RETROGRADE PYELOGRAM, URETEROSCOPY AND HOLMIUM LASER LITHOTRIPSY. LASER FIBER SNAPPED WHILE NOT IN USE ON PATIENT; SLIGHT DELAY IN CASE AS NEW FIBER WAS NEEDED. NO HARM TO PATIENT AS IT WAS NOT IN USE WHEN IT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274095 FORTEC BARE HOLMIUM FIBERS POWERED LASER SURGICAL INSTRUMENT GEX TRIMEDYNE, INC. 1P-724

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR