FDA.reportPublic FDA data

MAUDE MDR 8127795

MDR report key
8127795
Report number
8010047-2018-02367
Event key
0
Event type
3
Date of event
2018-11-12
Date received
2018-12-04
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 KAZUTAKA MATSUMOTO
Address
2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8 JA
Phone
426-426-4264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EVIS LUCERA ELITE XENON LIGHT SOURCEXENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCTCLV-290Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-040

Event Narratives#

N

Patient 1

THE SUBJECT CLV-290 HAS BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, HOWEVER THE EVALUATION IS IN PROGRESS AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE CLV-290 INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

DURING THE PROCEDURE OF PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY), THE ERROR "E202" OCCURRED AND THE ENDOSCOPIC IMAGE WAS DISAPPEARED. ?E202? IS THE ERROR THAT ?THE LIGHT SOURCE HAS BROKEN DOWN?. THE USER REPLACED THE SUBJECT CLV-290 WITH THE SIMILAR DEVICE, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT?S INJURY REGARDING THIS EVENT.