MAUDE MDR 8834772

MDR report key: 8834772
Report number: 8010047-2019-02713
Event key: 0
Event type: 3
Date received: 2019-07-28
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 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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE	BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	BF-UC190F						R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-07-28	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04953170233210	ULTRASONIC CABLE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2021-12-20
04953170391378	US CONNECTOR CAP	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2021-12-17
04953170399831	EVES EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2021-02-04
04953170243226	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2017-10-06
04953170243233	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2017-10-06
04953170341823	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2017-10-06
04953170341830	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2017-10-06
04953170356353	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2017-10-06
04953170355592	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21
04953170355608	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21
04953170355653	ULTRASONIC CABLE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21
04953170355660	Ultrasonic cable	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21
04953170355677	ULTRASOUND CABLE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21
04953170356360	EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	PSV	2016-09-21

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K183525	PSV	EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F	Olympus Medical Systems Corp.	2019-09-06
510(k)	K070983	PSV	OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM	Olympus Medical Systems Corporation	2007-07-05
510(k)	K021204	PSV	OLYMPUS BF TYPE UM40	Olympus Optical Co., Ltd.	2002-05-01