BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 8789620 · Received July 15, 2019

    Report

    Report Number
    3003701944-2019-00022
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 12, 2019
    Report Date
    October 7, 2019
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RECEIVED FOR INVESTIGATION: THE SAMPLE WAS RETURNED IN AN OPEN SECONDARY PACKAGE. THE SAMPLE INCLUDED AN DS, A SHUNT WRAPPED INTO A GAUZE INSIDE THE SEPARATE PLASTIC BAG AND LABELS. THE DS WIRE WAS PRESSED DOWN. THE DS WIRE PROTRUDED FROM THE CANNULA OPENING. 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 HAVE BEEN NO OTHER COMPLAINTS FOR THE LOT. THE ROOT CAUSE IS INCONCLUSIVE - UNABLE TO VERIFY AS THE DS TRIGGER WAS OPERATED AND PERFORMED ITS FUNCTIONALITY RELEASING THE SHUNT (SHUNT WAS RECEIVED SEPARATELY FROM THE DS). THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. 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 HAVE BEEN NO OTHER COMPLAINTS FOR THE LOT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A GLAUCOMA FILTRATION DEVICE PROCEDURE, THE SHUNT WAS UNABLE TO BE RELEASED WHILE BEING INSERTED INTO THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED WITH A NEW SHUNT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584767 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 073188

    Patients

    Seq Age Sex Outcome Treatment
    1