BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE SIS ENDO

    MDR report key: 3861260 · Received May 20, 2014

    Report

    Report Number
    3861260
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    January 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299580 SLIMLINE SIS ENDO POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, LTD. * *
    299652 SLIMLINE SIS ENDO POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, LTD, * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *