BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPROBE 23G TAPERED

    MDR report key: 2110886 · Received March 25, 2011

    Report

    Report Number
    2939653-2009-00006
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    October 15, 2009
    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 REPRESENTATIVE (B)(4) WAS CONTACTED BY PHONE ON (B)(6) 2011 TO FOLLOW UP ON PT STATUS. (B)(4) STATED THAT THERE WERE NO REPORTED INJURIES OR DETERIORATION AS A RESULT OF THE PRODUCT MALFUNCTION DURING THE INTENDED SURGICAL PROCEDURE. AS OF (B)(6) 2010 THE PT HAD IMPROVEMENT IN MACULAR CONTOUR AND DECREASED SUBRETINAL AND INTRARETINAL FLUID, AND ALL IS PROGRESSING WELL. IRIDEX RESPONDED TO THIS INCIDENT (DATED (B)(6) 2010) UPON REQUEST FROM THE FDA. CONCLUSION: TWO PROBES WERE RETURNED FOR EVAL. ONE PROBE FUNCTIONED AS EXPECTED. HOWEVER, THE OTHER PROBE HAD A RESISTOR THAT WAS NOT ELECTRICALLY CONNECTED. NON ELECTRICALLY CONNECTED RESISTORS IN THE PROBE ARE NOT UNUSUAL AND HAVE A KNOWN FAILURE RATE OF LESS THAN 0.1%. THE SYMPTOMS REPORTED BY THE COMPLAINANT HOWEVER, ARE MOST LIKELY CAUSED BY A WORN CONNECTOR ON THE LASER. THE RESISTOR USED TO VERIFY THAT THE CORRECT LASER WAS ATTACHED TO THE CORRECT PROBE WAS NOT FULLY ELECTRICALLY CONNECTED. THIS CAUSED THE DEVICE TO BE NOT "RECOGNIZED" BY THE LASER. NON ELECTRICALLY CONNECTED RESISTORS IN THE PROBE ARE NOT UNUSUAL AND HAVE A KNOWN FAILURE RATE OF LESS THAN 0.1%. THE ASSOCIATED RISKS FOR THIS FAILURE MODE ARE CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT AN IRIDEX 20G LASER PROBE WAS OPENED AND CONNECTED, BUT THE USERS NOTICED A VERY DIM AIMING BEAM. PER THE SURGEON, THE PROBE WAS REPLACED WITH A NEW PROBE. THE SECOND PROBE HAD AN AIMING BEAM SHAPED "LIKE A FIGURE 8". A THIRD PROBE WAS OPENED AND FUNCTIONED WELL. 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 20G VICTRECTOMY/MP/C3F8/LEFT EYE2. ENDOLASER RIGHT EYE. 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 23G TAPERED OPHTHALMIC LASER PROBE GEX IRIDEX CORP. 013143

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR