BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 8627604 · Received May 21, 2019

    Report

    Report Number
    3003701944-2019-00016
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Report Date
    August 18, 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 AND INVESTIGATED: THE DELIVERY SYSTEM (DS) WIRE WAS PRESSED DOWN. THE SHUNT WAS NOT LOADED ONTO THE DS WIRE BUT FIXED ON THE DS HANDLE (SEE INVESTIGATION FORM FOR PICTURES). THE DS WIRE WAS PULLED BACK, SLIGHTLY 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 CHANGES IN THE RAW MATERIAL/SUPPLIER, PROCESSES AND TECHNICIANS PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THE LOT. ALL PRODUCTS PASS 100% FINAL INSPECTION PRIOR TO APPROVAL. IF A DEFECT WOULD BE NOTICED, THE PRODUCT WOULD HAVE BEEN REJECTED. THE ROOT CAUSE CANNOT BE IDENTIFIED AS THE DS TRIGGER WAS OPERATED AND PERFORMED ITS FUNCTIONALITY RELEASING THE SHUNT (SHUNT WAS FIXED TO THE DS HANDLE, NOT LOADED ONTO THE DS WIRE TIP). 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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A SHUNT COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM WHILE BEING IMPLANTED INTO A PATIENT'S EYE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423670 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 073163

    Patients

    Seq Age Sex Outcome Treatment
    1