FDA.reportPublic FDA data

MAUDE MDR 5613216

MDR report key
5613216
Report number
8010047-2016-00599
Event key
0
Event type
3
Date of event
2016-04-05
Date received
2016-04-27
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
MR. SUSUMU NISHINA
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, 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
1VISERA ELITE XENON LIGHT SOURCELIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCTCLV-S190Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-2701. H; 2. O

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS CHECKED THE SUBJECT DEVICE, AND THERE WAS NO ABNORMALITY OF THE SUBJECT DEVICE. THE CAUSE OF THIS DEFECT WAS NOT CONCLUSIVELY DETERMINED AT THIS TIME. THE CAUSE WAS PRESUMABLY ATTRIBUTED TO FOLLOWING 2 ITEMS SINCE THE DEVICE WORKED PROPERLY ONCE THE FACILITY TURNED ON THE DEVICE AGAIN. THE DEVICE DID NOT WORK WHEN THERE WAS ABNORMAL POWER SUPPLY ENVIRONMENT TEMPORARILY IN THE FACILITY. THE SAFETY MECHANISM WORKED BECAUSE OF RISING INTERNAL TEMPERATURE IN THE DEVICE. OLYMPUS ALSO CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS STATED THE APPROPRIATE HANDLING OF THE SUBJECT DEVICE IN THE INSTRUCTION MANUAL WHEN THE SUBJECT DEVICE HAD ABNORMALITIES.

D

Patient 1

OLYMPUS WAS INFORMED THAT THE EXAMINATION LAMP OF THE SUBJECT DEVICE WENT OFF AND THE ERROR CODE (E102) WAS SHOWN TO A MONITOR DURING THE RECONSTRUCTIVE OPERATION OF BILIARY TRACT. THE EXAMINATION LAMP OF THE SUBJECT DEVICE LIT UP ONCE THE FACILITY TURNED ON THE DEVICE AGAIN. HOWEVER, THE FACILITY CONVERTED THE PROCEDURE TO AN OPEN SURGERY, BECAUSE THE FACILITY WAS ALARMED. THE OPEN SURGERY WAS COMPLETED. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.