BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC-500

    MDR report key: 6235623 · Received January 9, 2017

    Report

    Report Number
    0002936921-2016-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    NIDEK INCORPORATED
    Product Code
    HQF
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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. SERVICE EVALUATION: ON (B)(6) 2016, NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AT CUSTOMER'S SITE AND THE LASER JUST DIDN'T WORK RIGHT DURING LASER PERIPHERAL IRIDOTOMY (LPI) PROCEDURES. FSE FOUND THE SLIT-LAMP MICROSCOPE HEAD LOOSE ON THE STEM DUE TO ITS SET SCREW BEING BACKED OUT AND NOT LOCKING INTO POSITION. BOTH OCULARS WERE SET AT -8 AND THE FOCUS OF THE 50 MICRON SPOT SIZE WAS NOT IN THE SLIT-LAMP'S FOCAL PLANE AND MISALIGNED TO THE LEFT OF THE SLIT ILLUMINATION. THE FIBER AND CONTROL CABLE ON TOP OF THE VIXI DELIVERY WERE UNDER STRESS CAUSING THE STRAIN POLE TO BEND. THE FIXATION ROD, BASE LOCKING KNOB AND BIO SWITCH LEVER COVER ARE MISSING. GREEN SHOT COUNTER = 99817. FSE ALIGNED THE SLIT-LAMP MICROSCOPE HEAD INTO THE CORRECT POSITION, TIGHTENED ITS LOCKING SET SCREW. FOCUSED THE AIMING BEAM SPOT SIZE 50 TO 500 MICRONS. ALIGNED THE AIMING AND ILLUMINATION SLIT BEAMS AND SET THE MANIPULATOR KNOBS TO THEIR MIDDLE POSITION. TESTED AND INSPECTED THE SYSTEM FOR PROPER OPERATION IN BIO, SINGLE SHOT AND SCAN PATTERN SLIT-LAMP MODES. · DEVICE FUNCTIONED PROPERLY WITH NO FOCUS ISSUE AFTER TIGHTENED OF THE LOCKING SET SCREW ON THE SLIT-LAMP MICROSCOPE HEAD. ADDITIONAL INFORMATION: · ON 12.13.2016, NIDEK INC. MDR SPECIALIST WAS ABLE TO COMMUNICATE WITH THE CUSTOMER VIA E-MAIL, THE CUSTOMER HAVE PROVIDED THE TREATMENT SETTINGS DURING USED, PATIENT AFFECTED, BUT MEDICAL INTERVENTION WERE NOT AVAILABLE. · ON 12.14.2016, NIDEK INC. MDR SPECIALIST WAS ABLE TO GET CONFIRMATION WITH FSE VIA E-MAIL THAT THE LPI TREATMENT SETTINGS USED WERE NORMAL. · BASED ON THE PREVIOUS SERVICE ON THE LOW POWER ISSUE PERFORMED ON 10.25.2016, THE FSE WHO EVALUATED THE DEVICE LAST MONTH DID NOT NOTICE ANY TOWER BEING LOOSE. FINDINGS: NIDEK INC DETERMINED THAT THE PROBABLE CAUSE FOR THE CUSTOMER'S COMPLAINT ISSUE WAS DUE TO LOOSE SET SCREW ON THE SLIT-LAMP MICROSCOPE HEAD CAUSING IT TO NOT LOCK INTO POSITION. OVERTIME USAGE COULD HAVE CONTRIBUTED TO THE ISSUE OR SOMEONE COULD HAVE INADVERTENTLY LOOSENED THE MOUNTING SET SCREW NOT KNOWING THE CONDITIONS LEAD TO THE DIFFICULTY ENCOUNTERED DURING THE LPI PROCEDURES. HOWEVER AT THIS POINT, THE SUGGESTED ASSESSMENTS ARE INCONCLUSIVE AS NO STRONG EVIDENCE AND ADDITIONAL INFORMATION PROVIDED. THUS, THE DEVICE FUNCTIONED PROPERLY AFTER MINOR ALIGNMENT ON THE SLIT-LAMP MICROSCOPE HEAD INTO THE CORRECT POSITION AND TIGHTENING THE SET SCREW. THIS IS A RARE AND FIRST OCCURRENCE OF THIS ISSUE BASED ON COMPLAINT FREQUENCY ANALYSIS.

    Description of Event or Problem · 1

    ON DECEMBER 12, 2016, NIDEK INC. SALES MANAGER RECEIVED AN E-MAIL FROM A CUSTOMER TO REPORT THAT SEVERAL OF THEIR PATIENTS HAVE COMPLAINED OF PAIN AND DISCOMFORT AFTER RECEIVING LASER PERIPHERAL IRIDOTOMY (LPI) PROCEDURES FROM THEIR MULTICOLOR LASER PHOTOCOAGULATOR MC-500 SERIAL #(B)(4). THE CUSTOMER ADDED THAT THE ISSUES OCCURRED AFTER COMPLETING A SERVICE FROM NIDEK INC FOR "LOW POWER" WHICH WAS PERFORMED ON OCTOBER 25, 2016. THE CUSTOMER CONFIRMED THAT EIGHT PATIENTS WERE INVOLVED BUT NO SERIOUS INJURY AND NONE REQUIRED ANY MEDICAL INTERVENTION. THUS, EIGHT MEDWATCH FORM 3500A REPORTS WILL BE SUBMITTED FOR EACH PATIENT UNDER MDR 0002936921-2016-00004 THROUGH MDR 0002936921-2016-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15433 MC-500 MULTICOLOR LASER PHOTOCOAGULATOR HQF NIDEK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR