BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRES MNI GLAUCOMA SHUNT

    MDR report key: 2481130 · Received March 2, 2012

    Report

    Report Number
    3003701944-2012-00009
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 2, 2012
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. 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. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2012 BY PHONE. (B)(4).

    Description of Event or Problem · 1

    A CLINICAL DIRECTOR REPORTED DURING GLAUCOMA FILTRATION SURGERY THE SHUNT HAD NO FLOW. SHE STATED THE SHUNT WAS REMOVED DURING THE SAME PROCEDURE AND A SECOND SHUNT WAS IMPLANTED. THE CLINICAL DIRECTOR REPORTED THE SECOND SHUNT ALSO HAS NO FLOW AND WAS REMOVED. SHE STATED THE SURGERY WAS THEN CONVERTED TO A TRABECULECTOMY WITH NO HARM TO THE PATIENT. IN A FOLLOW-UP, A TECHNICIAN REPORTED THE PATIENT IS STABLE AND DOING VERY WELL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRES MNI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL LTD. P-50 PL 112119

    Patients

    Seq Age Sex Outcome Treatment
    1 MITOMYCIN C