BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUS 2000 DUAL FIBER

    MDR report key: 121914 · Received September 19, 1997

    Report

    Report Number
    2914019-1997-00026
    Event Type
    Malfunction
    Date Received
    September 19, 1997
    Date of Event
    June 10, 1997
    Report Date
    June 10, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION REVEALED PROBLEM WAS WITH THE PCB USED IN THIS EYE SAFETY FILTER DRIVER. THE PCB WAS DEFECTIVE AND CAUSED INTERMITTENT FAILURE OF THE CIRCUIT OPERATION. THE DESIGN WAS EVALUATED AND FOUND TO BE SUFFICIENT.

    Description of Event or Problem · 1

    WHILE IN GREEN MODE, DR REPORTED A BRIGHT LIGHT, NOT SURE OF COLOR (FLASHBACK). SYSTEM HAS A DUAL DRIVER BOX AND IS USED IN ENDO MODE. DRIVER BOX WAS DELAYING ONE FILTER FROM COMING INTO PLACE AND ALLOWING THE SYSTEM TO FIRE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 DUAL FIBER OPHTHALMIC LASER HQF COHERENT MEDICAL LASER GROUP 0615-611-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN