BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3130338 · Received May 22, 2013

    Report

    Report Number
    3003701944-2013-00040
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 24, 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

    THE SHUNT ARRIVED MOUNTED ON THE EDS. THE PRODUCT WAS FUNCTIONALLY TESTED AND WAS FOUND TO BE PROPER. THE COMPLAINT COULD NOT BE CONFIRMED, AS THE PRODUCT PASSED THE FUNCTIONAL TEST. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AND DOES NOT SEEM TO BE DEVICE RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE GLAUCOMA SHUNT WAS UNABLE TO BE RELEASED FROM THE DELIVERY SYSTEM, ALTHOUGH THE SURGEON PUSHED THE RELEASE BOTTOM STRONGLY. THE PROCEDURE WAS PERFORMED WITH AN ALTERNATIVE SHUNT. AFTER SURGERY, IT WAS CONFIRMED THAT THE WIRE OF THE DELIVERY SYSTEM WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227502 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 122923

    Patients

    Seq Age Sex Outcome Treatment
    1