BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC-500

    MDR report key: 14567262 · Received June 1, 2022

    Report

    Report Number
    0002936921-2022-00006
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 1, 2022
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HQF
    PMA / PMN Number
    K133358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED CUSTOMER'S MC-500 AND BIO DELIVERY AT THE CUSTOMER'S SITE ON (B)(6) 2022 AND DETERMINED THAT THE CAUSE OF NO AIMING BEAM WAS DUE TO A BROKEN BIO FIBER OPTIC CABLE. THE BIO FIBER OPTIC CABLE DELIVERS THE LASER BEAM FROM THE MAIN BODY TO THE DELIVERY UNIT AND SHARES THE EMISSION OF BOTH AIMING BEAM AND TREATMENT BEAM. THE FIBER OPTIC CABLE MAY HAVE BEEN PULLED OR GRABBED WHEN THE BIO WAS DROPPED. DUE TO THE BROKEN FIBER CABLE, THE TREATMENT BEAM WAS ALSO FOUND TO BE WEAK WITH THE POWER OUTPUT MEASURED AT A SETTING OF 300MW BEING 0.018MW (MUCH LESS THAN THE REQUIRED OUTPUT +/-20%). CUSTOMER INITIALLY REPORTED THAT "THE AIMING BEAM FADED OUT BUT THE LASER BEAM WAS STILL EMITTED.", HOWEVER, WITH THE DAMAGED FIBER OPTIC CABLE AND OUTPUT MEASUREMENT CLOSE TO 0MW, IT CAN BE CONCLUDED THAT ANY BRIEF LASER EMISSION OCCURRING AFTER THE AIMING BEAM FADED OUT WOULD HAVE NO EFFECT ON THE PATIENT'S EYE. TO RESOLVE THE ISSUE, THE BIO FIBER OPTIC CABLE WAS REPLACED (PART#11041-G116). AFTER THE FIBER OPTIC CABLE REPLACEMENT, THE RED AIMING BEAM BECAME VISIBLE, AND LASER ENERGY WAS WITHIN SPECIFICATION FOR ALL LASER COLORS 300MW=300MW. CUSTOMER'S MC-500 WAS VERIFIED AS OPERATIONAL. AS A PREVENTIVE MEASURE, FSE ADDITIONALLY NOTED THAT THE CUSTOMER WAS ADVISED THAT THE FIBER WAS DAMAGED AND INSTRUCTIONS ON THE PROPER HANDLING OF THE FIBER CABLE (RG-043-4) WERE PROVIDED. THE BIO OPERATOR'S MANUAL ALSO INCLUDES THE PRECAUTION, "TO AVOID DETERIORATION IN LASER DELIVERY PERFORMANCE, BE CAREFUL NOT TO BUMP THE FIBER OPTIC CABLE (FROM DROPPING OR HITTING)".

    Description of Event or Problem · 0

    ON (B)(6) 2022, NIDEK INC. SERVICE MANAGER RECEIVED A PHONE CALL FROM A CUSTOMER TO REPORT THAT DURING A VERY LONG SURGERY PROCEDURE, THE AIMING BEAM FADED OUT BUT THE LASER BEAM WAS STILL EMITTED. ISSUE OCCURRED DURING SURGERY; LATE FRIDAY, (B)(6) 2022. NO INJURY WAS REPORTED FROM THE CUSTOMER. DURING CONTINUED COMMUNICATION WITH THE CUSTOMER, THE CUSTOMER ALSO MENTIONED ON (B)(6) 2022 THAT "THE MACHINE WAS USED IN ALL SETTINGS - RED, GREEN AND YELLOW AT SOME POINT DURING THE DAY. RED SETTING WAS BEING USED WHEN THE AIMING BEAM WENT OUT." IN ORDER TO FINISH THE PROCEDURE, CUSTOMER "UTILIZED OTHER RED DIODE LASER SYSTEM" OF ANOTHER LASER COMPANY AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NIDEK INC. CONSIDERS THIS EVENT AS A REPORTABLE EVENT AS THE MALFUNCTION ASSOCIATING TO THE AIMING BEAM OCCURRED DURING TREATMENT. AIMING BEAM IS AN ESSENTIAL FUNCTION OF THE DEVICE TO AID POSITIONING OF THE LASER BEAM. THE MALFUNCTION COULD CAUSE/ CONTRIBUTE TO SERIOUS INJURY IF THE AIMING BEAM GOES OUT UNINTENTIONALLY DURING THE TREATMENT WHILE LASER CONTINUES TO BE EMITTED (MISPOSITIONING OF THE LASER BEAM MAY LEAD TO INJURY). RECURRENCE OF THIS ISSUE MAY ALSO INCREASE THE CHANCE OF INJURY. TECHNICAL BACKGROUND: THE NIDEK MULTICOLOR LASER PHOTOCOAGULATOR MC-500 IS A LASER PHOTOCOAGULATOR FOR OPHTHALMOLOGY WITH THE LIGHT SOURCE OF WAVELENGTHS 647, 577 AND 532 NM. AS THE CONVENTIONAL LASER PHOTOCOAGULATORS, THE MC-500 CAN BE USED FOR RETINAL PHOTOCOAGULATION FOR TREATMENT OF OCULAR FUNDUS DISEASES LIKE DIABETIC RETINOPATHY, AGE-RELATED MACULAR DEGENERATION, RETINOPATHY OF PREMATURITY AND RETINAL DETACHMENT OR LASER IRIDOTOMY AND LASER TRABECULOPLASTY FOR TREATMENT OF GLAUCOMA. THE MC-500 IS INTENDED TO BE USED IN OPHTHALMIC SURGICAL PROCEDURES, INCLUDING RETINAL AND MACULAR PHOTOCOAGULATION, IRIDOTOMY AND TRABECULOPLASTY. THE BINOCULAR INDIRECT OPHTHALMOSCOPE (HEREAFTER CALLED BIO) DELIVERY UNIT IS CONNECTED TO THE NIDEK MULTICOLOR LASER PHOTOCOAGULATOR, MODEL MC-500 (MAIN BODY), TO COMPRISE THE PHOTOCOAGULATION SYSTEM AND APPLIED TO THE TREATMENT OF THE AFFECTED AREA USING THE BIO DELIVERY UNIT (HEINE OMEGA 500). THE POWER OUTPUT OF THE TREATMENT BEAM IS SET WITH THE POWER BUTTONS OR POWER CONTROL IN INCREMENTS OF 10MW. THE POWER OUTPUT IS 50MW AT THE MINIMUM AND THE MAXIMUM POWER OUTPUT VARIES ACCORDING TO THE LASER COLOR (RED: 800MW, YELLOW: 1500MW, GREEN: 1700MW). THE POWER OUTPUT IS INCREASED WITH THE UPPER BUTTON AND DECREASED WITH THE LOWER BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305230 MC-500 MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM HQF NIDEK CO. LTD. MC-500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown