FDA.reportPublic FDA data

MAUDE MDR 4304381

MDR report key
4304381
Report number
3002807715-2014-00037
Event key
0
Event type
3
Date of event
2014-01-01
Date received
2014-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NEO YAMAGUCHI
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
1RT-1500REFRACTORNIDEK CO., LTD.HKNRT-5100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-010

Event Narratives#

D

Patient 1

NIDEK RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2014. DURING THE USE OF RT-5100; SN (B)(4), THE NEAR POINT CHART ARM FELL DOWN AND HIT THE DOCTOR ON HIS NOSE. DOCTOR GOT CUT ON HIS NOSE. DOCTOR ALSO REPORTED THAT THIS INCIDENT HAPPENED AFTER THE PREVENTIVE MAINTENANCE WAS DONE FOR THE RECALL.

N

Patient 1

THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, A NIDEK SERVICE ENGINEER (SE) HAD CONDUCTED AN ON-SITE EVALUATION. THE DEVICE WAS EVALUATED. SE FOUND THE HINGE (P/NO. 82001CB033) HAD DEGRADED FAILURE. THE PART WAS REPLACED AND THE PREVENTIVE MAINTENANCE WAS DONE ACCORDING TO THE RECALL PROCEDURE. THE NEAR POINT CHART ARM HAS BEEN FIXED. NIDEK CONTACTED THE CUSTOMER TO VERIFY THE COMPLAINT ABOUT THE CUT ON THE NOSE AND CONFIRMED THAT THE INJURY WAS MINOR. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. NIDEK INC. CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.