BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPLAN SIDEFIRE LASER

    MDR report key: 27919 · Received October 25, 1995

    Report

    Report Number
    1420001-1995-00005
    Event Type
    Malfunction
    Date Received
    October 25, 1995
    Date of Event
    September 18, 1995
    Report Date
    October 18, 1995
    Manufacturer
    MYRIADLASE, INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PARTICULAR HEALTHCARE FACILITY HAS REPORTED THAT THEY HAVE EXPERIENCED TIP DETACHMENT FROM THREE LASER FIBERS ON TWO SEPARATE OCCASIONS (SAME PHYSICIAN). NONE OF THE EVENTS RESULTED IN SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPLAN SIDEFIRE LASER OPTICAL LASER FIBER HQF MYRIADLASE, INC. 25441 50327

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other