BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIDEX G-PROBE

    MDR report key: 4894455 · Received July 3, 2015

    Report

    Report Number
    2939653-2015-00001
    Event Type
    Malfunction
    Date Received
    July 3, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 2, 2015
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED AS A FOLLOW UP TO THE INITIAL MDR 2939653-2015-00001 FILED ON 07/03/2015. WRITTEN CORRESPONDENCE FROM THE TREATING PHYSICIAN STATES THAT THE PATIENT'S BURN MARKS HAVE RESOLVED. AS INDICATED IN THE INITIAL REPORT, THE IRIDEX OCULIGHT SLX LASER (SN (B)(4)) USED FOR THE PROCEDURE WAS SERVICED BY THE USER FACILITY AFTER THE REPORTED INCIDENT AND THE LASER WILL NOT BE RETURNED TO IRIDEX FOR INVESTIGATION. IRIDEX HAS RECEIVED FROM THE USER FACILITY SERVICE REPORTS FOR THE MAINTENANCE EVALUATION CONDUCTED ON THE LASER BOTH PRIOR TO THE REPORTED INCIDENT, AND AFTER THE REPORTED INCIDENT, AS THE UNIT HAS NOT BEEN RETURNED TO IRIDEX FOR SERVICE SINCE 2004. BASED ON THE USER-FACILITY EVALUATION CRITERIA OF ELECTRICAL SAFETY TESTING (ONLY) THE UNIT PASSED SPECIFICATIONS. IRIDEX HAS REQUESTED THAT THE USER FACILITY RETURN THE UNIT FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    PER USER FACILITY REPRESENTATIVE THEY SERVICE LASERS EVERY SIX MONTHS AND THE IRIDEX OCULIGHT SLX LASER WAS SERVICED IN (B)(4) 2014. THE LASER WAS SERVICED BY THE USER FACILITY AFTER THE REPORTED INCIDENT AND WILL NOT BE RETURNED TO IRIDEX FOR INVESTIGATION. IRIDEX HAS REQUESTED FURTHER INFORMATION REGARDING THE LASER SERVICING BUT HAS NOT RECEIVED A RESPONSE FROM THE USER FACILITY. BOTH THE G-PROBE INVOLVED IN THE INCIDENT, AND THE SECOND PROBE USED IN THE SUCCESSFUL PROCEDURE WERE RETURNED TO IRIDEX FOR INVESTIGATION. THE G-PROBE USED IN THE REPORTED INCIDENT (PN 11256-1, LOT 015839) INVESTIGATION REVEALED THE CONNECTOR WAS RECOGNIZED BY THE LASER. THE RESISTANCE MEASURED 1.683 KOHMS, WHICH MEETS SPEC (ACCEPTABLE RANGE IS 1.665 - 1.715 KOHMS). WITH THE LASER SET TO 250MW, THE MEASURED POWER OUTPUT WAS 192MW, OUT OF SPEC. THE POWER OUTPUT OF THE AIMING LASER WAS 0.430MW. VISUAL INSPECTION OF THE TIP INDICATED THAT IT WAS VERY DIRTY AND THE AREA OF THE TIP WHERE THE FIBER PROTRUDES, APPEARED TO BE DAMAGED AND POSSIBLY MELTED. THE BALL-LENS END OF THE FIBER APPEARED DIRTY AS WELL. THE DAMAGE FOUND IS CONSISTENT WITH THAT OCCURRING DUE TO IMPROPER CLEANING. EXCESSIVE DEBRIS ON THE TIP OF THE FIBER COULD CAUSE THE BALL-LENS TO DELIVERY ENERGY TO THE EYE IN AN UNINTENDED PATTERN. THE SECOND G-PROBE (PN 11256-1) USED FOR THE SUCCESSFUL COMPLETION OF TREATMENT WAS RETURNED WITHOUT PACKING, SO THE LOT NUMBER WAS NOT IDENTIFIABLE. INVESTIGATION REVEALED THE CONNECTOR WAS RECOGNIZED BY THE LASER. THE RESISTANCE MEASURED 1.689 KOHMS, WHICH MEETS SPEC (ACCEPTABLE RANGE IS 1.665 - 1.715 KOHMS). WITH THE LASER SET TO 250MW, THE MEASURED POWER OUTPUT WAS 254MW, IN SPEC. THE POWER OUTPUT OF THE AIMING LASER WAS 0.547M. THE TIP LOOKED CLEAN AND UNDAMAGED. IRIDEX WARNS THE PHYSICIANS, THROUGH THE INSTRUCTION FOR USE (IFU) AND THE USER MANUAL, TO CLEAN THE G-PROBE DURING USE TO AVOID TISSUE ACCUMULATION. ALSO, IT INSTRUCTS PHYSICIANS TO KEEP THE EYE IRRIGATED THROUGHOUT THE ENTIRE PROCEDURE. IF ORGANIC MATERIAL IS ALLOWED TO ACCUMULATE ON THE FIBER FACE, THE TIP REMAINS HIGHLY ABSORBING FOR SUBSEQUENT LASER PULSES, UNTIL THE DEBRIS IS REMOVED. ONCE CONTAMINATION OCCURS, THE USE OF THE CONTAMINATED DEVICE SHOULD BE DISCONTINUED AS RECOMMENDED, AND THE DEVICE SHOULD BE DISCARDED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED TO IRIDEX ON (B)(6) 2015, THAT TREATING PHYSICIAN BEGAN CYCLOPHOTOCOAGULATION PROCEDURE WITH AN IRIDEX G-PROBE (PN 11256-1, LOT # 015839) WHEN HE NOTICED THAT THE PROBE BURNED UPON INITIAL TREATMENT. WRITTEN FOLLOW-UP FROM THE TREATING PHYSICIAN REPORTED "UPON NOTICING A DEEP THICKNESS BURN I IMMEDIATELY STOPPED TREATMENT AND TURNED DOWN THE POWER SETTINGS. I THEN APPLIED THE PROBE TO TREAT AGAIN ONLY TO HAVE ANOTHER BURN WOUND. I THEN TURNED DOWN THE POWER SETTINGS TO THE LOWEST I COULD GO AND STILL HAD A BURN WOUND. I THEN ASKED THE NURSE TO GIVE ME A COMPLETELY DIFFERENT PROBE AND PROCEEDED WITH TREATMENT AS MY USUAL COURSE WITHOUT ANY ADVERSE EVENTS." TREATMENT PARAMETERS INITIALLY SET ON THE IRIDEX OCULIGHT SLX LASER (SN (B)(4)) WERE 2000MW (POWER) AND 2000MS (PULSE DURATION). THE PATIENT WAS NOT BEING TREATED IN AN AREA OF PIGMENTATION, AND THERE WAS NO DEBRIS IDENTIFIED ON THE TIP PRIOR TO USE. TREATING PHYSICIAN REPORTED THAT HE BELIEVED THE PATIENT MAY HAVE HAD A PRIOR CATARACT PROCEDURE ON THE EYE TREATED WITH THE G-PROBE). ). BSS (BALANCED SALT SOLUTION) WAS USED TO MAINTAIN MOISTURE DURING THE PROCEDURE. PROBE WAS ONLY USED FOR 3-4 TREATMENT SPOTS AND THEN CHANGED OUT FOR ANOTHER NEW PROBE. I USUALLY LOOK FOR A POP (END-POINT) BEFORE TREATING, ALTHOUGH SOMETIMES YOU DON'T GET THIS RESPONSE. PATIENT SUSTAINED A NEAR FULL THICKNESS BURNS (THE BURN SPANNED ALMOST THE FULL DEPTH OF SCLERA AND INTO CILIARY BODY) WHICH WERE TREATED WITH MAXITROL OINTMENT AND COVERED. PATIENT POST-OP DOING WELL BUT HAS PRETTY NOTICEABLE BURN MARKS ON THE CONJUNCTIVA AT THE AREA OF TREATMENT. IRIDEX HAS CONTACTED THE TREATING PHYSICIAN FOR FURTHER FOLLOW-UP REGARDING THE PATIENT'S STATUS BUT, TO DATE, HAS NOT RECEIVED A REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433991 IRIDEX G-PROBE OPHTHALMIC LASER PROBE GEX IRIDEX CORPORATION 11256-1 015839

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR