BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE EZ 200 SINGLE USE FIBER DEVICE

    MDR report key: 3874127 · Received June 10, 2014

    Report

    Report Number
    MW5036587
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY, URETEROSCOPY, LASER LITHOTRIPSY AND STENT PLACEMENT PROCEDURE, THE LASER FIBER BROKE OFF, APPROXIMATELY 2.5 CM OF FIBER BROKE OFF IN THE PATIENTS LEFT URETER AND/OR RENAL PELVIS DURING LITHOTRIPSY PROCEDURE. PER SURGEON, IT WAS UNEXPECTED AS THERE HAD BEEN NO TORQUE APPLIED TO THE SCOPE OR FIBER DURING THE MANIPULATION OF THE STONE AND NO SIGNIFICANT FLEXION OF THE TIP WAS USED TO ACCESS THE STONE. AS HE MANIPULATED THE TIP BACK, IT WAS NOT VISIBLE AND HE BECAME AWARE THAT THE TIP HAD FRACTURED WITHIN THE URETEROSCOPE. THE SCOPE WAS WITHDRAWN AND THE PROCEDURE ABORTED. THE PATIENT WAS APPRISED AND WAS RESCHEDULED TO HAVE SURGERY TO ATTEMPT TO REMOVE THE TIP AND TREAT THE UNTREATED STONE, HOWEVER THE PATIENT RETURNED TO OUR FACILITY ON (B)(6) 2014 AFTER HAVING PASSED THE FIBER WHILE URINATING. THE FIBER APPEARS INTACT, AND THE PATIENT DID HAVE SURGERY TO TREAT THE UNTREATED STONE, HOWEVER, THERE WAS ON INJURY NOTED AT THAT TIME FROM PASSING THE FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338578 SLIMLINE EZ 200 SINGLE USE FIBER DEVICE LASER FIBER GEX BOSTON SCIENTIFIC 99060813

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other