BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTRAIL SINGLE USE FIBER

    MDR report key: 4350974 · Received December 12, 2014

    Report

    Report Number
    3006897895-2014-00002
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    December 11, 2014
    Manufacturer
    STARMEDTEC GMBH
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL 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 THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT # 3006897895-2014-00001 FOR INFO ON THE OTHER ASSOCIATED DEVICE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO STARMEDTEC THAT A LIGHT TRAIL SINGLE USE LASER FIBER WAS USED DURING A URETEROSCOPY AND LASER TRIPSY PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PT. IT WAS REPORTED THAT THE BROKEN FRAGMENT WAS NOT RETRIEVED AND WAS NOT OBVIOUSLY VISIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTRAIL LASER FIBER. THERE WERE NO REPORTED PT COMPLICATIONS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808062 LIGHTRAIL SINGLE USE FIBER POWERED LASER SURGICAL INSTRUMENT GEX STARMEDTEC GMBH 2013-00449

    Patients

    Seq Age Sex Outcome Treatment
    1