BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 6964846 · Received October 20, 2017

    Report

    Report Number
    3003288808-2017-02254
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    February 16, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY¿S ACCEPTANCE CRITERIA. THE SYSTEM WAS REPLACED WITH A LOANER AND WAS SENT FOR REPAIR AND EVALUATION. THE ERROR COULD BE REPRODUCED. THE EVALUATION IS DONE WITH THE SUPPLIER AND IS STILL IN PROGRESS. THE ROOT CAUSE COULD NOT BE IDENTIFIED CONCLUSIVELY UNTIL THE SAMPLE EVALUATION IS NOT FINISHED. THE MOST LIKELY ROOT CAUSE IS A DEFECT OF CAMERA ELECTRONICS DUE TO WEAR. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CLINIC'S ENGINEER/TECHNICIAN REPORTED NON-TRUSTY MEASUREMENT RESULTS DURING DIAGNOSTIC TESTING ON SEVEN PATIENTS. THERE IS NO POSSIBILITY TO RE-MEASURE CORRECTLY. ALL THE REQUIRED STEP-BY-STEP TROUBLESHOOTING WAS DONE BUT THE PROBLEM STILL REMAINS AND UNIT IS UNSTABLE. UPON FOLLOW UP, IT WAS REPORTED THAT MEASUREMENTS WERE NOT USED FOR THE PATIENTS SURGERY. NO UNEXPECTED END RESULTS OCCURRED. NO PATIENT HARM REPORTED. SEVEN PATIENTS WERE REPORTED INVOLVED. THERE WERE NO UNEXPECTED END RESULTS REPORTED. NO PATIENT INFORMATION WAS AVAILABLE AS THE DOCTOR DID NOT USE RESULTS OF MEASUREMENTS BECAUSE THEY WERE NOT TRUSTY. ANOTHER PIECE OF EQUIPMENT WAS USED FOR DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743638 ALLEGRO OCULYZER DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other