BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO OCULAR LASER PROBES 25G THUMB ADJUSTABLE PROBE

    MDR report key: 2114403 · Received April 27, 2011

    Report

    Report Number
    2939653-2011-00021
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    August 11, 2008
    Report Date
    April 24, 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

    THIS DOCUMENT IS ASSOCIATED WITH MAUDE MDR REPORT KEY #1158343. THE PROBES LISTED BELOW WERE IDENTIFIED TO BE ASSOCIATED WITH THE IRIDEX COMPLAINT RECORD. PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND THE LOT MET OUR ACCEPTANCE CRITERIA. MODEL: 15488T-1 (25G THUMB ADJUSTABLE PROBE), LOT: 8050211, MANUF: 05/2008, EXPIRE: 05/01/2011. PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND THE LOT MET OUR ACCEPTANCE CRITERIA. MODEL: 15482T-1 (20G THUMB ADJUSTABLE PROBE), LOT: 8010462, MANUF: 03/2008, EXPIRE: 03/01/2011. TWO DEVICES WERE RETURNED AND EVALUATED. ONE HAD A BURNED FIBER, AND THE OTHER HAD LOW POWER. DEBRIS ON THE FIBER COULD CREATE A HOT SPOT AND BURN IN THE FIBER. BURNED FIBERS OCCUR AT A LOW RATE. MODEL: 14344-1 (20G ADJUSTABLE PROBE), LOT: 747484. PRODUCT WAS NOT RETURNED. THIS DEVICE DOES NOT APPEAR TO BE AN IRIDEX DEVICE.

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT "DURING PROCEDURE" IT WAS NOTED THAT THE LASER FIBER WAS NOT FUNCTIONING. RN NOTICED A RED "HOT SPOT" TOWARDS THE END OF THE LASER FIBER. ALL PERSONNEL IN THE ROOM WERE WEARING APPROPRIATE LASER GOGGLES. NEW FIBER WAS OBTAINED AND FUNCTIONED PROPERLY. MALFUNCTIONING PROBE WILL BE RETURNED TO MANUFACTURER FOR EVALUATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO OCULAR LASER PROBES 25G THUMB ADJUSTABLE PROBE OPHTHALMIC LASER PROBES GEX IRIDEX CORP. 15488T-1 8020843

    Patients

    Seq Age Sex Outcome Treatment
    1