BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 10119188 · Received June 4, 2020

    Report

    Report Number
    3003288808-2020-00339
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    March 13, 2020
    Report Date
    July 31, 2020
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY¿S ACCEPTANCE CRITERIA. A REVIEW OF THE LOGFILES COULD CONFIRM CUSTOMER REPORTED EVENT. DURING AN ONSITE VISIT, THE FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED EVENT AND PERFORMED PREVENTIVE MAINTENANCE. FSE REPLACED CARD AND THE FLASH BECAUSE THE MEMORY CONTAINS SPECIAL CHARACTERS. FSE FOUND A POWER STRIP BOX ON WHICH THE LASER AND THE BED WERE NOTABLY PLUGGED INTO WAS DEFECTIVE AND MAKES IT BREAK DOWN IF YOU TURN ON ITS SWITCH. BY PLUGGING IN THE LASER AND READING IT ON ANOTHER POWER STRIP, THERE WAS NO PROBLEM. IT IS INDEED THE POWER STRIP BOX THAT WAS DEFECTIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NO UDI REQUIRED DUE TO THIS DEVICE WAS OUT OF PRODUCTION PRIOR TO THE SEPTEMBER 24, 2014 UDI REGULATION DATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CLIENT REPORTED TWO INTERRUPTED TREATMENTS. IT WAS REPORTED THAT INTERRUPTED TREATMENT COULD ALWAYS BE RESUMED AFTERWARDS IF THE CORRECTION WAS NOT SUFFICIENT. A COMPANY REPRESENTATIVE REPLACED THE CARD TO SOLVE THE PROBLEM. NEW INFORMATION WAS RECEIVED. THE DEVICE ITSELF COMPLETELY CUTS OFF. THERE WAS NO POWER FAILURE. EVERYTHING ELSE WAS WORKING. THIS OCCURS ON BOTH EYES OF THE PATIENT. THEY WENT TO ANOTHER ROOM AND USED ANOTHER LASER. A CALL WAS RECEIVED THAT THE POWER STRIP THAT THE LASER AND BED WERE PLUGGED INTO WAS FOUND TO BE DEFECTIVE BY THE CLINIC. THE LASER AND BED WERE PLUGGED INTO A NEW POWER STRIP AND THEY WORKED FINE. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585518 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR