BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO OCULAR PROBE 23G

    MDR report key: 2110929 · Received March 25, 2011

    Report

    Report Number
    2939653-2010-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2010
    Report Date
    March 25, 2011
    Manufacturer
    IRIDEX CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY REP (B)(6) WAS CONTACTED BY PHONE ON 03/24/2011 TO F/U ON PT STATUS. (B)(6) STATED THAT IT APPEARS A THIRD PROBE WAS OPENED AND IT PERFORMED AS EXPECTED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO OPERATIVE COMPLICATIONS. SHE REQUESTED THAT THE PROBES BE RETURNED TO HER SO THAT SHE COULD SEND THEM TO IRIDEX FOR EVAL. SHE EXPLAINED THAT SHE NEVER RECEIVED THE PROBES. THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. A LOT MET OUR FINAL ACCEPTANCE CRITERIA. NOTED DISCREPANCY IN THE REPORTED PRODUCT LOT NUMBER. PRODUCT LOT NUMBER REFERENCED IN THIS REPORT IS LOT #9010185. LOT NUMBER REPORTED ON USER FACILITY REPORT #(B)(4) IS LOT #9010185. LOT NUMBER REPORTED ON FDA VOLUNTARY REPORT #(B)(4) DATED 07/08/2010 AND SUBMITTED TO IRIDEX IS LOT #8070214.

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT TWO ENDOLASER PROBES FAILED DURING RETINA SURGERY. NEITHER PROBE SHOWED AN OPTIMAL AIMING BEAM, AND NEITHER PROBE FIRED EFFECTIVELY. ONE PROBE SHOWED AN OBVIOUS BROKEN FIBER CLOSE TO THE END THAT PLUGS INTO THE LASER UNIT. USER FACILITY REPORTS THAT THE EVENT DID NOT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE. USER FACILITY REPORTS THAT THE ORIGINAL INTENDED PROCEDURE WAS A PARS PLANA VITRECTOMY. USER FACILITY REPORTS THAT THE DEVICE USAGE PROBLEM WAS A MALFUNCTION - THE DEVICE DID NOT PERFORM AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO OCULAR PROBE 23G OPHTHALMIC LASER PROBE GEX IRIDEX CORP. 9010185

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR