MAUDE MDR 4603327

MDR report key: 4603327
Report number: MW5041373
Event key: 0
Event type: 3
Date received: 2015-03-05
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 305
Health professional: 0
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	UNK	UNK ENDOSCOPIC DEVICE.		ODD

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2015-03-05	0	1. H

Event Narratives#

D

Patient 1

I WAS SCHEDULED TO HAVE AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, AFTER THE PROCEDURE I DEVELOPED E.COLI SEPTICEMIA AND ACUTE PANCREATITIS. THIS WAS BACK IN 2001, BUT I AM HOWEVER WONDERING IF THIS HAS BEEN GOING ON LONGER THAN RECENT NEWS HAS REPORTED. AT THE TIME THE DOCTOR HAD ATTEMPTED TO USE A NEW (TO HIM) DEVICE AND A MEDICAL SALESMAN WAS IN THE ROOM AT THE TIME OF MY PROCEDURE. I BELIEVE HE COULD NOT ACHIEVE THIS GOAL AND USED THE OLD DEVICE, I DON'T KNOW WHICH TOOL (THE NEW OR THE OLD ONE) INTRODUCED THE E. COLI INTO MY SYSTEM. I SPOKE TO A WOMAN NAMED (B)(6) FROM MY AREA THAT WORKS FOR THE FDA AND SHE SUGGESTED I CONTACT THE AGENCY THROUGH THIS METHOD. I AM NOT SURE IF IT MATTERS AT ALL BUT AS I STATED BEFORE I DON'T THINK THIS IS A NEW PROBLEM FOR THESE DEVICES. I STILL HAVE MY MEDICAL RECORDS FROM THIS EVENT.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04953170466045	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466052	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466069	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466076	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466083	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466090	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466106	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466113	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
04953170466120	Single Use 2-Lumen Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466042	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466059	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466066	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466073	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466080	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466097	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466103	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466110	Single Use Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
14953170466127	Single Use 2-Lumen Cannula V	OLYMPUS MEDICAL SYSTEMS CORP.	ODD	2025-06-12
00827002214521	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002215009	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002219656	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002220935	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002222267	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002223028	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002223059	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002226210	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002227194	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002245068	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002246935	COOK	COOK INCORPORATED	ODD	2022-12-08
00827002246942	COOK	COOK INCORPORATED	ODD	2022-12-08

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K250573	ODD	Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M	Olympus Medical Systems Corp.	2025-05-27
510(k)	K202583	ODD	BioShield biopsy valve EUS - Linear	STERIS Corporation	2020-11-06
510(k)	K171989	ODD	Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter	Wilson-Cook Medical, Inc.	2018-03-20
510(k)	K070420	ODD	BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138	United States Endoscopy Group, Inc.	2007-03-19
510(k)	K011149	ODD	DISPOSABLE BENDING CANNULA PR-233Q	The Olympus Optical Co.	2001-05-15

MAUDE MDR 4603327

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Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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