BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTRAIL REUSABLE FIBER

    MDR report key: 5046430 · Received August 14, 2015

    Report

    Report Number
    3006897895-2015-00004
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 10, 2015
    Manufacturer
    STARMEDTEC GMBH
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, NOT YET BEGUN. THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO STARMEDTEC ON (B)(6) 2015 THAT LIGHTRAIL REUSABLE LASER FIBER WAS USED DURING A PROCEDURE USING AN OLYMPUS URETEROSCOPE (42 FR CHANNEL) PERFORMED ON (B)(6) 2015. REPORTEDLY, THE FIBER WAS USED TO BREAK UP A STONE. ACCDG TO THE COMPLAINT, THIS WAS THE FIRST USE OF THIS REUSABLE FIBER AND DURING THE PROCEDURE, THE LASER FIBER BROKE NEAR THE TIP. THERE WERE NO REPORTED PATIENT COMPLICATIONS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540603 LIGHTRAIL REUSABLE FIBER POWERED LASER SURGICAL INSTRUMENT GEX STARMEDTEC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1