BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVS APEX PLUS EXCIMER LASER WORKSTATION

    MDR report key: 272100 · Received March 30, 2000

    Report

    Report Number
    1287364-2000-00004
    Event Type
    Malfunction
    Date Received
    March 30, 2000
    Date of Event
    March 17, 2000
    Report Date
    March 20, 2000
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER SITE NOTICED THAT AN O-RING WAS MISSING FROM THE EMPHASIS CASSETTE. THE EMPHASIS DISC MAY NOT BE PROPERLY ALIGNED IF THE O-RING IN THE EMPHASIS CASSETTE IS NOT PRESENT. THE SUCCESS OF CERTAIN PROCEDURES IS DEPENDENT ON PROPER ALIGNMENT OF THE DISC WITHIN THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVS APEX PLUS EXCIMER LASER WORKSTATION EXCIMER LASER SYSTEM LZS SUMMIT TECHNOLOGY, INC. UV325000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other