BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEL80 EXCIMER LASER SYSTEM

    MDR report key: 6679707 · Received June 29, 2017

    Report

    Report Number
    9615030-2017-00011
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    April 27, 2017
    Report Date
    June 29, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    LZS
    PMA / PMN Number
    P060004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EVALUATION OF THE MEL80 EXCIMER LASER SYSTEM. THE REPORTED ERROR MESSAGE AND TERMINATION OF LASER PROCEDURE WERE DUE TO A FAILURE OF THE SHUTTER. AFTER REPLACEMENT OF THE DEFECTIVE SHUTTER THE DEVICE WAS CONFIRMED TO BE WORKING WITHIN SPECIFICATION. TERMINATION OF LASER PROCEDURE, IN THE EVENT OF SHUTTER FAILURE, IS AN INTENDED SYSTEM MONITORING FUNCTION OF THE MEL80. THE SHUTTER INTERRUPTS LASER EMISSION BY CLOSING TO PREVENT HUMAN EXPOSURE TO LASER RADIATION. THE TREATMENT CAN BE CONTINUED AT A LATER TIME. THE USER MANUAL (320817-0300-000-DOKS-FR-090117, 320817-0300-000-DOKS-GB-171212, PAGE 114) INSTRUCTS IN CASE OF SHUTTER ERROR, "CONFIRM THE MESSAGE. IF THIS ERROR REOCCURS, SWITCH OFF THE DEVICE AND CONTACT THE EXCIMER LASER HOTLINE".

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE MEL80 EXCIMER LASER STOPPED AFTER 39% OF A REFRACTIVE SURGICAL PROCEDURE WAS COMPLETED. THE SYSTEM DISPLAYED ERROR #208, RELATED TO THE SHUTTER. THE HCP HAD TO ABORT THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460343 MEL80 EXCIMER LASER SYSTEM EXCIMER LASER SYSTEM LZS CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR