MAUDE MDR 9462807

MDR report key: 9462807
Report number: 8010047-2019-04293
Event key: 0
Event type: 3
Date received: 2019-12-12
Adverse event: 3
Product problem: 0
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 SMALL INTESTINAL VIDEOSCOPE	SMALL INTESTINAL VIDEOSCOPE	OLYMPUS MEDICAL SYSTEMS CORP.	FDA	SIF-Q260						R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-12-12	0	1. O

Event Narratives#

N

Patient 1

THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. AS PART OF OUR INVESTIGATION, OMSC REVIEWED ALL OF THE COMPLAINTS FOR THE PERIOD, BUT THERE WAS NO RECORD ASSOCIATED WITH THE EVENT DESCRIBED IN THE ARTICLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS RECEIVED JDDW (JAPAN DIGESTIVE DISEASE WEEK) LITERATURE ABSTRACT THAT STATED THE RESULT OF THE ENDOSCOPIC TREATMENT FOR BILE DUCT STONES USING WITH SBE-ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING WITH SINGLE BALLOON ENDOSCOPE) AND ULTRASOUND ENDOSCOPE TO THE PATIENTS WHOM HAD EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY. THE LITERATURE ABSTRACT REPORTED THE RESULT OF THE ERCP PROCEDURES FOR BILE DUCT STONES IN 117 CASES FROM APRIL 2011 TO MARCH 2019. AS ACCIDENTAL SYMPTOMS, THE PANCREATITIS OCCURRED IN 5 CASES AFTER THE ERCP PROCEDURES, THE SMALL PERFORATION OCCURRED IN 1 CASE DURING THE PRE-CUT. THE EACH PATIENTS WERE TREATED CONSERVATIVELY. THE INTESTINAL PERFORATION OCCURRED IN 2 CASES AND IT REQUIRED THE OPEN ABDOMINAL SURGERY. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. OMSC IS SUBMITTING MDR ACCORDING TO THE NUMBER OF TYPES OF THE ACCIDENTAL SYMPTOM. THIS IS 4 OF 8 REPORTS. (4 OF 5 PANCREATITIS CASES).

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00348783012415	Premier Jackson Improved Short Tracheostomy Tube	PREMIER DENTAL PRODUCTS COMPANY	FDA	2026-06-10
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

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 9462807

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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