BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3162047 · Received June 6, 2013

    Report

    Report Number
    3003701944-2013-00043
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 8, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. 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. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS BEEN RECEIVED ON (B)(4) 2013. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED THAT DURING A GLAUCOMA FILTRATION SHUNT IMPLANTATION, THE SHUNT WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. ADDITIONAL INFORMATION RECEIVED. THE SURGEON REPORTED THE SHUNT WAS LOOSE IN THE CANAL, REMOVED THE SHUNT AND PERFORMED A TRABECULECTOMY. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251624 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 124314

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR MYTOMYCIN C| 27 GAUGE NEEDLE| CAUTERY| 9-0 VICRYL SUTURE