BEUDAMED
    FDA Adverse Event Summary report: N

    SLIMLINE EZ 200

    MDR report key: 2871340 · Received November 23, 2012

    Report

    Report Number
    2871340
    Date Received
    November 23, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LASER FIBER WAS IN USE INSIDE PATIENT. SURGEON AND STAFF HEARD AN AUDIBLE POP SOUND AND THE LASER FIBER BROKE. FIBER WAS ABLE TO BE REMOVED FROM PATIENT AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE EZ 200 POWERED LASER SURGICAL INSTRUMENT, HOLMIUM FIBER GEX BOSTON SCIENTIFIC 840-892 63690312

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR