BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTRAC

    MDR report key: 4109680 · Received August 12, 2014

    Report

    Report Number
    4109680
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SINGLE USE HOLMIUM LASER FIBER ACCUTRAC 200 #840-411 WAS DEFECTED, WHEN FIBER WAS ATTACHED TO LASER, IT WOULD NOT WORK. THE DOCTORS NEEDED TO OPEN ANOTHER FIBER WHICH WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479723 ACCUTRAC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 840-411 MLK00002259

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR