BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2852090 · Received November 14, 2012

    Report

    Report Number
    3003701944-2012-00078
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 15, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. 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 PRODUCT'S LUMEN WAS VISUALLY INSPECTED AND WAS FOUND TO BE BLOCKED. AFTER CLEANING THE LUMEN APPEARED TO BE CLEAN. THERE WAS ONE SIMILAR COMPLAINT REPORTED IN THE LOT FROM THE SAME FACILITY. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING GLAUCOMA FILTRATION SURGERY, THE DEVICE DID NOT WORK PROPERLY. WHEN THE SHUNT WAS IN PLACE, IT WAS VERIFIED THAT THERE WAS NO DRAINAGE OF AQUEOUS HUMOR THROUGH THE SHUNT, IT SEEMED BLOCKED. THREE ADD'L SHUNTS WERE USED DURING THE SAME PROCEDURE AND ALSO HAD NO DRAINAGE. THE SURGERY WAS THEN CONVERTED TO A TRABECULECTOMY WITH NO HARM TO THE PT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 120513

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR