FDA.reportPublic FDA data

MAUDE MDR 5982365

MDR report key
5982365
Report number
8010047-2016-01249
Event key
0
Event type
3
Date of event
2016-08-31
Date received
2016-09-28
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 XENON LIGHT SOURCELIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCTCLV-S40Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-280

Event Narratives#

N

Patient 1

THE SUBJECTED DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. OMSC EVALUATED THE DEVICE AND FOUND THE FOLLOWING. - OMSC COULD NOT FIND THE SIGNATURE OF THE ELECTRICAL SHORT CIRCUIT. - THE DUST WAS NOT DEPOSITED. - THE LAMP WAS ATTACHED WITHOUT THE SLIP. - THE HEAT-COMPOUND WAS PASTED PROPERLY. - THE LAMP GAS WAS NOT LEAKED. - THE LAMP WAS TURNED ON WITHOUT ANY ABNORMALITY. - THE STANDBY MODE COULD NOT BE ACTIVATED. - THE BRIGHTNESS SELECTOR COULD NOT BE ACTIVATED. - THE EMERGENCY LAMP COULD NOT BE TURNED ON. - THE LAMP LIFE METER COULD NOT BE DISPLAYED. THE CLV-S40 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

OLYMPUS WAS INFORMED THE FOLLOWING INFORMATION. THE USER FACILITY CHANGED THE LAYOUT WITH THE MOVING OF THE HOSPITAL. THE USER FACILITY MOUNTED THE SUBJECT DEVICE TO THE TROLLEY UNTIL THEN. AFTER THE MOVING OF THE HOSPITAL, THE USER FACILITY MOUNTED THE SUBJECT DEVICE TO THE CEILING PENDANT MADE BY (B)(6). AFTER THAT, THE USER FACILITY TURNED ON THE SUBJECT DEVICE, AND THE WHITE SMOKE OCCURRED FROM THE BACK OF THE LAMP BOX OF THE SUBJECT DEVICE. THE USER FACILITY TURNED OFF THE SUBJECT DEVICE. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.