BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3042914 · Received March 5, 2013

    Report

    Report Number
    3003701944-2013-00016
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    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: ALL PRODUCTS PASS 100% FINAL INSPECTION. THE SHUNT'S INNER LUMEN WAS FOUND TO BE PROPER, WITH NO BLOCKAGE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THE COMPLAINANT STATEMENT "FOREIGN MATERIAL IN THE LUMEN" COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AND DOES NOT SEEM TO BE DEVICE RELATED. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A PROCEDURE TO IMPLANT A GLAUCOMA FILTRATION SHUNT, AFTER INSERTION, IT COULD NOT BE CONFIRMED THAT THERE WAS AQUEOUS FLOW. THE SURGEON FOUND A FOREIGN SUBSTANCE LIKE A METAL FRAGMENT OF THE WIRE IN THE LUMEN. THE GLAUCOMA SHUNT WAS EXCHANGED FOR A DIFFERENT ONE, BUT NO FLOW COULD NOT BE CONFIRMED WITH THIS SHUNT EITHER. THE SURGERY WAS COMPLETED WITHOUT EXPLANTATION OF THE GLAUCOMA SHUNT. THE SURGEON REPORTED NO PT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED THIS EVENT. THIS IS FOR THE FIRST SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94736 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122006

    Patients

    Seq Age Sex Outcome Treatment
    1