BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200 MICRON FIBER WITH FLAT TIP

    MDR report key: 2170651 · Received July 21, 2011

    Report

    Report Number
    1419951-2011-00006
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    December 20, 2010
    Report Date
    July 18, 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 HIS FORM. (B)(4). NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4). MATERIAL SEPARATION. DEVICE NOT RETURNED--EVALUATION BASED ON REPORTER'S NARRATIVE. (B)(4) DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    OR TECH PLUGGED IN UNIT AND WENT TO TURN ON LASER. FIBER SPARKED NEAR THE CONNECTION TO THE LASER, AND EMERGENCY STOP SWITCH WAS PRESSED. SURGEON USED A DIFFERENT METHOD FOR THE PROCEDURE. THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 200 MICRON FIBER WITH FLAT TIP LASER FIBER GEX TRIMEDYNE, INC. B200 R909026

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR