BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPROBE, 23G STRAIGHT

    MDR report key: 2110933 · Received April 1, 2011

    Report

    Report Number
    2939653-2011-00013
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    November 2, 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 RECORD WAS CONDUCTED. THE LOT MET OUR FINAL ACCEPTANCE CRITERIA. CONCLUSION: 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 PT UNDERWENT A POSTERIOR VITRECTOMY. THE LASER COULD NOT READ THE "FIBER" AND, THEREFORE, DID NOT WORK. NO PT INFO PROVIDED. 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 POSTERIOR 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 ENDOPROBE, 23G STRAIGHT OPHTHALMIC LASER PROBE GEX IRIDEX CORP. 14390-1 013043

    Patients

    Seq Age Sex Outcome Treatment
    1