BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 200

    MDR report key: 3030377 · Received March 27, 2013

    Report

    Report Number
    MW5029551
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER TIP BROKE OFF INSIDE THE PT'S KIDNEY DURING SURGERY. SURGEON WAS ABLE TO RETRIEVE THE TIP USING A BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126499 SLIMLINE 200 LASER FIBER GEX BOSTON SCIENTIFIC 58731211

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention