BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 5176773 · Received October 26, 2015

    Report

    Report Number
    3003701944-2015-00667
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Report Date
    December 9, 2015
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THERE ARE NO OTHER COMPLAINTS IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED FOR INVESTIGATION IN THE FOLLOWING MANNER: THE SHUNT WAS NOT ON THE DELIVERY SYSTEM (DS), THE DS WIRE WAS FULLY DEPRESSED AND IT DID NOT PROTRUDE FROM THE CANNULA OPENING. IN LIGHT OF THE PRODUCT CONDITION AS RECEIVED FOR INVESTIGATION, IT SEEMS THAT THE DS TRIGGER WAS HANDLED AND PERFORMED ITS FUNCTIONALITY. DUE TO THE ABOVE REASONING THE COMPLAINT CANNOT BE JUSTIFIED. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE - UNABLE TO VERIFY, AND NO FURTHER ACTION IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT DURING A FILTERING GLAUCOMA SHUNT IMPLANTATION SURGERY, THE SHUNT WAS UNABLE TO BE RELEASED FROM THE INSERTER. ANOTHER SHUNT WAS USED INSTEAD. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709148 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 144018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other