BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX 200 LITHOTRIPSY FIBER

    MDR report key: 3182537 · Received June 14, 2013

    Report

    Report Number
    2937094-2013-00684
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 15, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER WAS FOUND TO BE BROKEN AND SEPARATED FROM THE CONNECTOR. THE FIBER TIP LOOKS BROKEN; THE BLUE OUTER SHEATH IS SEVERELY BURNT. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE EXCESSIVE BENDING/USER HANDLING AND/OR HEAT ACCUMULATION DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER SYSTEM STOPPED SUDDENLY AND THE FIBER WAS NOTICED TO BE BURNED NEXT TO THE CONNECTOR; A BLACK SPOT WAS OBSERVED. THE FIBER WAS REPLACED AND THE CASE COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272269 SUREFLEX 200 LITHOTRIPSY FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMS S-LLF200TG 2453B

    Patients

    Seq Age Sex Outcome Treatment
    1