BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 200

    MDR report key: 2771771 · Received September 30, 2012

    Report

    Report Number
    MW5027128
    Event Type
    Injury
    Date Received
    September 30, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USE OF BOSTON SCIENTIFIC SLIMLINE 200 LASER FIBER WITH HOLIMUM LASER FOR URETEROSCOPIC LASER LITHOTRIPSY ON A LOWER POLE STONE RESULTED IN FRACTURE OF THE LASER FIBER AND A RETAINED PIECE REQUIRING ADDITIONAL SURGERY TO RETRIEVE. LASER WAS FIRING, THEN AS FIBER ATTEMPTED TO BE PARTIALLY WITHDRAWN, REALIZED TIP WAS NOT CONNECTED. A PIECE APPROX 6 MM LONG HAD BROKEN OFF. REASON FOR USE: NEPHROLITHIASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 200 LASER FIBER DELIVERY DEVICES GEX BOSTON SCIENTIFIC M0068408400 65330412

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention