BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GALUCOMA SHUNT

    MDR report key: 3843595 · Received March 25, 2014

    Report

    Report Number
    3003701944-2014-00037
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 25, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS SENT FOR STERILIZATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE GLAUCOMA FILTRATION DEVICE (GFD) WAS UNABLE TO BE RELEASED FROM THE DELIVERY SYS, EVEN THOUGH THE BUTTON WAS PRESSED STRONGLY. THE SURGEON TRIED TO RELEASE THE DEVICE BY USING TWEEZERS, BUT WAS STILL UNABLE TO RELEASE THE DEVICE. THE DELIVERY SUS WAS REMOVED AND NEW GFD WAS IMPLANTED UNDER SCLERA. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174132 EX-PRESS MINI GALUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 132810

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK