BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPROBE, 20G TAPERED

    MDR report key: 2110932 · Received April 1, 2011

    Report

    Report Number
    2939653-2011-00012
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 10, 2009
    Report Date
    April 1, 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

    IRIDEX RESPONDED TO THIS INCIDENT (DATED (B)(6) 2010) UPON REQUEST FROM THE FDA. THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY WAS CONDUCTED. THE LOT MET OUR FINAL ACCEPTANCE CRITERIA. CONCLUSIONS: TWO PROBES WERE RETURNED FOR EVAL. ONE PROBE FUNCTIONED AS EXPECTED. HOWEVER, THE OTHER PROBE HAD A RESISTOR THAT WAS NOT ELECTRICALLY CONNECTED. (B)(4). THE SYMPTOMS REPORTED BY THE COMPLAINANT HOWEVER ARE MOST LIKELY CAUSED BY A WORN CONNECTOR ON THE LASER.

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT LASER PROBE HAD VIRTUALLY NO AIMING BEAM. REPLACED WITH ANOTHER PROBE AND SURGERY CONTINUED WITHOUT INCIDENT. 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 PARS PLANA VITRECTOMY, MEMBRANE STRIPPING, ENDOLASER, AIR-FLUID EXCHANGE, OD. 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 ENDOPROBE, 20G TAPERED OPHTHALMIC LASER PROBE GEX IRIDEX CORP. 10562-1 013083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR