BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2241407 · Received August 18, 2011

    Report

    Report Number
    3003701944-2011-00023
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT EVAL: THE SAMPLE WAS REC'D FOR EVAL AND THE INVESTIGATION IS IN PROGRESS. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A SHUNT NOT RELEASING WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO OPTONOL'S ACCEPTANCE CRITERIA. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED AND REC'D VIA PHONE ON (B)(4) 2011 AND (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPORTED THE SHUNT WOULD NOT RELEASE DURING GLAUCOMA FILTRATION SURGERY, AND THE BACKUP SHUNT WAS INSERTED WITH NO HARM TO THE PT.

    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 101906

    Patients

    Seq Age Sex Outcome Treatment
    1