BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICA - K5 LASER

    MDR report key: 71947 · Received February 28, 1997

    Report

    Report Number
    MW1010848
    Event Type
    Malfunction
    Date Received
    February 28, 1997
    Date of Event
    February 26, 1997
    Report Date
    February 28, 1997
    Manufacturer
    HGM MEDICAL LASER SYSTEMS, INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LASER DID NOT ENGAGE AND CAUSED LASER EXPOSURE TO THE SURGEON'S RIGHT EYE. THERE WAS NO ADVERSE EVENT PER RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICA - K5 LASER OPHTHALMIC LASER HQF HGM MEDICAL LASER SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN