BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000CXIII

    MDR report key: 6084565 · Received November 7, 2016

    Report

    Report Number
    0002936921-2016-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    NIDEK INCORPORATED
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE TECHNICAL BACKGROUND: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, MODEL EC-5000CXIII, IS AN OPHTHALMIC LASER SYSTEM USED FOR CORRECTION OF CORNEAL REFRACTION AND ABLATION OF THE CORNEAL SURFACE. THE SYSTEM IS COMPOSED OF A LASER GENERATOR WHICH PRODUCES AN EXCIMER LASER RADIATION OF WAVELENGTH 193NM, A BEAM DELIVERY UNIT, AN OPTICAL SYSTEM FOR OBSERVATION, A GAS SYSTEM, AND A COMPUTER FOR SYSTEM CONTROL. THE SYSTEM IS DESIGNED TO BE USER FRIENDLY FOR EASY AND SAFE OPERATION WITH NIDEK'S ADVANCED OPTOELECTRONIC TECHNOLOGY. AS WITH ALL LASER OUTPUT DEVICES, THE NIDEK EC-5000 CXIII EXCIMER LASER SYSTEM PRESENTS A POTENTIAL HAZARD TO PATIENTS AND OPERATORS. AVOID INADVERTENT DIRECT EXPOSURE OF SKIN AND EYES TO THE LASER. HEALTHCARE PERSONNEL WHO MAY APPROACH THE PATH OF THE PRIMARY BEAM SHOULD WEAR PROTECTIVE EYEWEAR. DEVICE SERVICE EVALUATION: A NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AT CUSTOMER'S SITE ON (B)(6) 2016 AND WAS ABLE TO OBSERVE THE ABLATION WAS OFF-CENTER TO THE 9 O'CLOCK POSITION. FSE TESTED ABLATION ON PMMA PLATE AND FOUND IT OFF-CENTER. ABLATION WAS LESS THAN 0.5MM OFF TO THE LEFT, ONLY PERFECT CENTER IS ACCEPTABLE. THE EYE TRACKING OFFSET WAS CHECKED AND IT WAS ALIGNED IN THE CENTER. PER EC-5000CXIII SERVICE MANUAL, ADJUSTMENT CAN BE MADE TO THE G10 MIRROR ASSY. (26202-2350) SO THE BURN PATTERN COMES IN THE CENTER OF ALIGNMENT ILLUMINATION. THEREBY, FSE MADE ADJUSTMENT BY PIVOTING THE G10 MIRROR MOUNT THAT WILL PUSH-PULL THE SCREWS AND RETESTED LASER FOR PROPER OPERATION. NO PROBLEM FOUND AFTER THE G10 MIRROR ADJUSTMENT MADE, DEVICE WAS FUNCTIONING PROPERLY. NIDEK INC. EVALUATION: DECENTERED ABLATION IS AN INFREQUENT COMPLICATION OF LASER EYE SURGERY THAT OCCURS WHEN THE TREATMENT IS NOT PROPERLY CENTERED OVER THE PUPIL. LASER ABLATIONS THAT ARE OFF-CENTER BY AS LITTLE AS 0.5MM CAN CAUSE VISUAL SYMPTOMS, INCLUDING GLARE AND HALOS, GHOST IMAGES, AND BLURRED VISION. ON 11.1.2016, A USER FACILITY TECHNICIAN CALLED AND CONFIRMED WITH A NIDEK INC. MDR SPECIALIST THAT CALIBRATION IS PERFORMED PRIOR TO PATIENT TREATMENT AND ADDED, THAT THE ISSUE WAS OBSERVED DURING THE DEVICE CALIBRATION BEFORE PATIENT TREATMENT AND AS A RESULT, NO PATIENT INJURY WAS REPORTED. PER EC-5000CXIII OPERATOR'S MANUAL, MAKE SURE TO CALIBRATE THE ABLATION RATE BEFORE THE ACTUAL SURGERY. THE SYSTEM DOES NOT ALLOW SURGERY TO BE PERFORMED UNLESS THE ABLATION RATE IS CALIBRATED. ALTHOUGH NO PATIENT INJURY OCCURRED, NIDEK INC. DOES CONSIDER ABLATION OFF-CENTER ON THE EXCIMER LASER AS A MEDICAL DEVICE REPORT, AS THERE COULD BE POTENTIAL ADVERSE IMPACT TO THE PATIENT IF THE EVENT WAS TO RECUR. FINDINGS: NIDEK INC. DETERMINED THAT THE PROBABLE CAUSE FOR THE CUSTOMER'S COMPLAINT ISSUE WAS DUE TO A MISALIGNED G10 MIRROR THAT HAD MECHANICALLY DRIFTED OUT OF POSITION. A NIDEK INC. REFRACTIVE COORDINATOR (EXPERT IN EXCIMER LASER) TECHNICAL ASSESSMENTS QUOTED THAT THE DOCTORS CAN EASILY ENGAGED THE JOYSTICK INADVERTENTLY NOT KNOWING THAT EYE TRACKING ALIGNMENT HAD MOVED OUT OF SPECIFICATION BECAUSE THE JOYSTICK IS LESS SENSITIVE - MOVES TOO QUICK OR THE (4) SCREWS ON THE G10 MIRROR SLIGHTLY GOT LOOSEN OVERTIME DURING A LONG PERIOD OF USED. HOWEVER AT THIS POINT, THE SUGGESTED ASSESSMENTS ARE INCONCLUSIVE AS NO STRONG EVIDENCE AND ADDITIONAL INFORMATION PRESENTED. THUS, THE DEVICE FUNCTIONED PROPERLY AFTER ADJUSTMENTS MADE TO THE G10 MIRROR. THE USER FACILITY HAS OWNED THIS MEDICAL DEVICE SINCE 11.2010, AND HAS HAD 30 SERVICE CALLS. ONE SIMILAR SERVICE CALL WAS NOTED ON 3.31.2011, THE EYE TRACKING HAD MISALIGNED WHICH CAUSED THE ABLATION TO OFF-CENTER AND IN RESOLUTION, THE EYE TRACKING JUST NEEDED ADJUSTMENT BACK TO CENTER POSITION. THE SITE HAD REPORTEDLY RECEIVED 16 ROUTINE PREVENTIVE MAINTENANCE SERVICE SINCE OWNERSHIP. THE LAST ROUTINE PM SERVICE WAS PERFORMED ON 6.23.16 AND A SCHEDULED PM WILL BE PERFORM AT THE END OF NOVEMBER 2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NIDEK INC. CUSTOMER SERVICE RECEIVED A TELEPHONE CALL FROM THE USER FACILITY TO REPORT THAT THE ABLATION WAS OFF-CENTER ON THE EC-5000CXIII SERIAL #(B)(4). DURING A ROUTINE CALIBRATION ON THE DEVICE, A CUSTOMER'S OFFICE TECHNICIAN OBSERVED THE ISSUE WHILE CHECKING THE ABLATION. UNABLE TO CONTINUE WITH TREATMENT AND THE USER FACILITY HAD REQUESTED SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732264 EC-5000CXIII EXCIMER LASER HQF NIDEK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1