BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX LITHOTRIPSY FIBER

    MDR report key: 3050201 · Received April 5, 2013

    Report

    Report Number
    2937094-2013-00374
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WITH A PT UNDER ANESTHESIA, NO LIGHT WAS EMITTING FROM THE FIBER, HOWEVER, THE USER REPORTED THAT SMOKE WAS EMITTING FROM THE FIBER CONNECTION POINT. ADD'L INFO IS NOT AVAILABLE. "NO INJURY TO PT" WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139822 SUREFLEX LITHOTRIPSY FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS S-LLF200TG 2453A

    Patients

    Seq Age Sex Outcome Treatment
    1