MAUDE MDR 8726626

MDR report key: 8726626
Report number: 8010047-2019-02270
Event key: 0
Event type: 3
Date received: 2019-06-24
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 LUCERA ELITE SMALL INTESTINALVIDEOSCOPE	SMALL INTESTINALVIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	SIF-H290S						R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-06-24	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00860014745003	FUJIFILM Stiffening Wire (SW-2000)	Fujifilm Healthcare Americas Corporation	FDA	2025-12-18
04547410491715	FUJIFILM	FUJIFILM CORPORATION	FDA	2024-07-05
04547410514056	FUJIFILM	FUJIFILM CORPORATION	FDA	2024-07-05
14547410491712	FUJIFILM	FUJIFILM CORPORATION	FDA	2024-07-05
14547410514053	FUJIFILM	FUJIFILM CORPORATION	FDA	2024-07-05
10197106523643	CARDINAL HEALTH	Cardinal Health 200, LLC	FDA	2024-01-24
50197106523641	CARDINAL HEALTH	Cardinal Health 200, LLC	FDA	2024-01-24
10197106447185	CARDINAL HEALTH	Cardinal Health 200, LLC	FDA	2023-11-09
50197106447183	CARDINAL HEALTH	Cardinal Health 200, LLC	FDA	2023-11-09
10860006600805	Ancora	Aspero Medical, Inc.	FDA	2023-10-26
00847627004703	CD138 + Cyclin D1	BIOCARE MEDICAL LLC	FDA	2023-06-21
04547410467284	FUJIFILM	FUJIFILM CORPORATION	FDA	2023-02-06
04547410324280	FUJIFILM	FUJIFILM CORPORATION	FDA	2023-02-06
04547410467260	FUJIFILM	FUJIFILM CORPORATION	FDA	2023-02-06
14547410467281	FUJIFILM	FUJIFILM CORPORATION	FDA	2023-02-06
04547410463439	FUJIFILM	FUJIFILM CORPORATION	FDA	2022-01-30
04953170165801	HANGER ADAPTER SET	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-17
04953170165825	PROBE ARM SET A	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-17
04953170165849	PROBE ARM SET B	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-17
04953170165740	STOPPER	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-16
04953170165757	WATER RESISTANT CAP	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-16
04953170165764	PROBE HANGER	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	2021-12-16
06934955960246	Jade PTA Balloon Dilatation Catheter	OrbusNeich Medical (ShenZhen) Co., Ltd.	FDA	2020-12-25
00052569143735	HealthMart	STRATEGIC SOURCING SERVICES LLC	FDA	2020-07-31
10052569143732	HealthMart	MCKESSON CORPORATION	FDA	2020-07-31
00075289122811	ProWorks	TRANZONIC COMPANIES, THE	FDA	2020-04-02
70075289122810	ProWorks	TRANZONIC COMPANIES, THE	FDA	2020-04-02
04547410384536	FUJIFILM	FUJIFILM CORPORATION	FDA	2019-07-04
00811503033316	Q UROLOGICAL PERSISTENT AGUAMEDICINA	Q UROLOGICAL CORPORATION	FDA	2019-03-27
10811503033306	Q UROLOGICAL PERSISTENT AGUAMEDICINA	Q UROLOGICAL CORPORATION	FDA	2019-03-27

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K260314	FDA	Ancora-SB	Aspero Medical, Inc.	2026-05-01
510(k)	K251204	FDA	FUJIFILM Stiffening Wire Device (SW-2000)	FUJIFILM Healthcare Americas Corporation	2025-09-26
510(k)	K233321	FDA	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	FUJIFILM Healthcare Americas Corporation	2024-06-13
510(k)	K231323	FDA	Ancora-SB	Aspero Medical, Inc.	2023-08-31
510(k)	K223295	FDA	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	Fujifilm Corporaton	2023-01-11

MAUDE MDR 8726626

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#