FDA.reportPublic FDA data

MAUDE MDR 5873189

MDR report key
5873189
Report number
3002807715-2016-00032
Event key
0
Event type
3
Date of event
2016-07-14
Date received
2016-08-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. PREETI BHATIA
Address
47651 WESTINGHOUSE DRIVE FREMONT CA 94539 US
Phone
510-510-5103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARK-10000OPD SCAN, REFRACTIVE POWER/CORNEAL ANALYZERNIDEK CO., LTDHKOARK-10000N/AN/AR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-120

Event Narratives#

N

Patient 1

IN-HOUSE SERVICE EVALUATION ACTIVITIES REVIEW: THE DEVICE WAS RETURNED TO NIDEK INC AND IN-HOUSE SERVICE ENGINEER (SE) EVALUATED THE DEVICE ON AUGUST 3, 2016 AND WAS NOT ABLE TO DUPLICATE OR VERIFY THE SMOKE COMING OUT FROM THE DEVICE. NO BURNT COMPONENT AND/OR PART OBSERVED DURING VISUAL INSPECTION. SE TESTED THE DEVICE AND OBSERVED THE FOLLOWING ISSUES: MAIN SWITCH FLIPS BACK TO "OFF" POSITION AS SOON AS THE DEVICE WAS TURNED "ON". ONE OF THE THREE XYZ MOTORS WAS OUT FROM THE BRACKET AND ALL THREE LN SCREWS WERE UNSCREWED FROM THE MOTOR BRACKET. ALL THREE SCREWS WERE FOUND IN THE BOTTOM OF THE SBC ASSEMBLY. SE DETERMINED THAT THE MAIN SWITCH WAS TURNING BACK TO "OFF" POSITION DUE TO SHORT CIRCUIT INSIDE THE JOYSTICK ASSEMBLY. SE REPLACED THE JOYSTICK ASSEMBLY (PART #32164-2200) INCLUDING THE JOYSTICK CIRCUIT BOARD (PART #32164-BA04) BUT OBSERVED SYSTEM TURNS "ON" INTERMITTENTLY. SE REPLACED THE DEVICE'S MOTHERBOARD (PART #32166-EA38) WHICH RESOLVED THE INTERMITTENT POWER "ON" ISSUE BUT THE MEASUREMENT HEAD WAS NOT MOVING UP/DOWN. SE TESTED WITH A NEW MAIN BOARD (PART #32164-BA01) BUT THE MEASUREMENT HEAD WAS NOT MOVING UP/DOWN. LASTLY, SE REPLACED XYZ MOTOR (PART # 32164-EA43) ALONG WITH THE MAIN BOARD AND PERFORMED AR/CT CALIBRATION. AFTER ALL AFFECTED PARTS REPLACEMENTS, THE DEVICE FUNCTIONED PROPERLY. SE DETERMINED THAT THE PROBABLE CAUSE FOR THE REPORTED COMPLAINT WAS INCONCLUSIVE. THERE WAS NO EVIDENCE OF A BURNT COMPONENT/PART FOUND BUT MAY HAVE LIKELY ASSOCIATED WITH A SHORT CIRCUITED JOYSTICK ASSEMBLY UNIT THAT EVENTUALLY CAUSED THE MAIN BOARD AND THE MOTHERBOARD TO GO BAD. ALSO, SE DETERMINED THAT THE THREE LN SCREWS FROM THE XYZ MOTOR WAS OUT FROM THE BRACKET WERE DUE TO OVERTIME USED. THE DEVICE HAS BEEN OPERATIONAL FOR 8 YEARS, THE USER FACILITY FIRST OWNED THE DEVICE SINCE JULY 2008 AND HAS HAD 5 SERVICE CALLS. HOWEVER, AFTER REVIEWING THE SERVICE CALLS RECORDS, THERE WAS NO RECORD OF THE AFFECTED PARTS BEING REPLACED. SINCE DEVICE MALFUNCTIONED OR NOT WORKING AS INTENDED OCCURRED, NIDEK INC CONSIDERS THIS ISSUE AS A REPORTABLE EVENT WHICH THERE IS MORE THAN A REMOTE CHANCE THAT A RECURRENCE OF THE MALFUNCTION WOULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY.

D

Patient 1

ON (B)(6) 2016, CUSTOMER CALLED NIDEK INC TO REPORT THAT THEIR ARK-10000, OPD-SCAN REFRACTIVE POWER/CORNEAL ANALYZER DEVICE SERIAL# (B)(4) WHEN POWERING ON, THEY SMELL SMOKE COMING FROM THE HEAD. DUE TO SMOKE COMING FROM THE HEAD OF THE OPD, CUSTOMER WAS UNABLE TO USE DEVICE UNTIL IT IS REPAIRED. NO PATIENT INJURY REPORTED FROM (B)(6) AND REQUESTED SERVICE REPAIR. NO PATIENT INFORMATION NEEDED AS THIS MDR HAD NO ADVERSE EVENT.