FDA.reportPublic FDA data

MAUDE MDR 5824688

MDR report key
5824688
Report number
8010047-2016-00988
Event key
0
Event type
3
Date of event
2016-06-22
Date received
2016-07-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. SUSUMU NISHINA
Address
2951 ISHIKAWA-CHO HACHIOJI-SH, TOKYO 192-8 JA
Phone
42-42-42 6
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EVIS EXERA III XENON LIGHT SOURCEXENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCTCLV-190Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-260

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INVESTIGATION BUT THE PHENOMENON WAS NOT REPRODUCED SO FAR. OLYMPUS WILL PERFORM FURTHER INVESTIGATION TO DETERMINE THE CAUSE OF THIS PHENOMENON. THERE WERE NO FURTHER DETAILS PROVIDED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

DURING THE UNSPECIFIED PROCEDURE, THE EXAMINATION LAMP OF THE SUBJECT DEVICE WENT OFF AND THE EMERGENCY LAMP DID NOT STARTED UP. THE USER COMPLETED THE PROCEDURE USING THE SAME CLV-190 BECAUSE AFTER THE USER TURNED ON THE SUBJECT DEVICE SEVERAL TIMES, THE SUBJECT DEVICE WORKED PROPERLY. THERE WAS NO REPORT OF THE PATIENT INJURY IN THIS EVENT

N

Patient 1

THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2016-00988 TO PROVIDE DEVICE EVALUATION RESULTS. OLYMPUS CHECKED FOLLOWING ITEMS OF THE SUBJECT DEVICE, AND THERE WAS NO ABNORMALITY FOUND. OLYMPUS CHECKED THE FUNCTION OF THE SUBJECT DEVICE. OLYMPUS CHECKED THE STATE OF THE CONNECTION OF THE HARNESS INSIDE THE SUBJECT DEVICE. OLYMPUS CHECKED THAT THERE WAS NO ABNORMALITY WITH LONG OPERATION OF THE SUBJECT DEVICE. OLYMPUS CHECKED THAT THERE WAS NO ABNORMALITY AT THE SUBJECT DEVICE WITH VIBRATION. ADDITIONALLY, THERE WAS DUST INSIDE THE SUBJECT DEVICE. OLYMPUS COULD NOT IDENTIFY THE CAUSE OF THE FAILURE OF THE EMERGENCY LAMP. OLYMPUS THINK THE SUBJECT DEVICE DID NOT WORK PROPERLY TEMPORARILY BY SOME CAUSE. IT IS CONSIDERED ACCIDENTAL FAILURE SINCE THE SIMILAR CONDITION OF CLV-190 DOESN'T OCCUR THE PAST 3 YEARS. OLYMPUS STATED THE APPROPRIATE HANDLING OF THE SUBJECT DEVICE IN THE INSTRUCTION MANUAL WHEN THE SUBJECT DEVICE HAD ABNORMALITIES. THERE WERE NO FURTHER DETAILS PROVIDED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.