FDA.reportPublic FDA data

MAUDE MDR 6803064

MDR report key
6803064
Report number
8010047-2017-01214
Event key
0
Event type
3
Date of event
2017-07-26
Date received
2017-08-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KATSUAKI MORITA
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
1XENON LAMPXENON LAMPOLYMPUS MEDICAL SYSTEMS CORP.GCTMD-6316CBC2809Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-180

Event Narratives#

N

Patient 1

THE SUBJECT MD-631 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC CONFIRMED THAT THE SUBJECT MD-631 DID NOT LIGHT UP AND THE REPORTED PHENOMENON COULD BE REPRODUCED. OMSC CONFIRMED THE CRACK ON THE GLASS PART OF THE SUBJECT MD-631. FROM ABOVE EVALUATION RESULTS, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS CAUSED BY LEAKING XENON GAS OF THE SUBJECT MD-631 FROM THE CRACK. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

D

Patient 1

AT THE FINAL STEP OF THE ESD, THE SUBJECT MD-631 IN THE CLV-260 NBI DID NOT LIGHT UP AND THE EMERGENCY LAMP LIGHTED UP. THE USER TURNED OFF AND RE-TURNED ON THE CLV-260NBI, BUT THE PHENOMENON WAS NOT SOLVED. THE USER REPLACED THE SUBJECT MD-631 MOUNTED IN THE CLV-260NBI WITH A SPARE MD-631 AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT?S INJURY REGARDING THIS EVENT.