BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVS APEX PLUS EXCIMER LASER WORKSTATION

    MDR report key: 271768 · Received March 30, 2000

    Report

    Report Number
    1287364-2000-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2000
    Date of Event
    February 28, 2000
    Report Date
    March 28, 2000
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED THAT DURING A TOPIC PROCEDURE, USING AN EMPHASIS "I" DISC, THE LASER'S ENDPOINT DETECTION SYSTEM DID NOT PROPERLY STOP THE PROCEDURE. THIS ALLEGED MALFUNCTION RESULTED IN MORE LASER PULSES BEING DELIVERED DURING TREATMENT THAN INTENDED.

    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. UV290000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other