BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVUS 2000

    MDR report key: 112107 · Received August 8, 1997

    Report

    Report Number
    2914019-1997-00023
    Event Type
    Other
    Date Received
    August 8, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 9, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTED THAT THE LASER WAS NOT WORKING. THE PROCEDURE PERFORMED WAS A RETINA DETACHMENT. DR HAD TO MANUALLY FINISH PROCEDURE. THERE WAS MORE BLEEDING THAN THERE WOULD HAVE BEEN IF LASER HAD WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 OPHTHALMIC LASER GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other