MAUDE MDR 9847434

MDR report key: 9847434
Report number: 3005099803-2020-00885
Event key: 0
Event type: 3
Date of event: 2020-02-24
Date received: 2020-03-18
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: CAROLE MORLEY
Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone: 508-508-5086
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	TRAPEZOID RX	LITHOTRIPTOR, BILIARY MECHANICAL	BOSTON SCIENTIFIC CORPORATION	LQC	1088	1088	0023916528				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-18	0	1. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00810143890921	Strauss Surgical	AMERICAN MEDICAL ENDOSCOPY, INC.	LQC	2024-04-15
04953170462597	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2024-03-25
04953170462610	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2024-03-25
14953170462594	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2024-03-25
14953170462617	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2024-03-25
04953170433658	Single Use BML Handle V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2022-09-16
14953170433655	Single Use BML Handle V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2022-09-16
00850033250664	Strauss Surgical	AMERICAN MEDICAL ENDOSCOPY, INC.	LQC	2022-08-12
00850033250671	Strauss Surgical	AMERICAN MEDICAL ENDOSCOPY, INC.	LQC	2022-08-12
04953170420290	Single Use Mechanical Lithotriptor BML-610A	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2021-12-17
14953170420297	Single Use Mechanical Lithotriptor BML-610A	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2021-12-17
00827002572836	COOK	COOK INCORPORATED	LQC	2021-05-05
04953170420283	OLYMPUS	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2019-12-10
14953170420280	OLYMPUS	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2019-12-10
08714729296379	Trapezoid RX	BOSTON SCIENTIFIC CORPORATION	LQC	2016-09-24
08714729296386	Trapezoid RX	BOSTON SCIENTIFIC CORPORATION	LQC	2016-09-24
08714729296393	Trapezoid RX	BOSTON SCIENTIFIC CORPORATION	LQC	2016-09-24
08714729296409	Trapezoid RX	BOSTON SCIENTIFIC CORPORATION	LQC	2016-09-24
00827002216044	Soehendra	COOK INCORPORATED	LQC	2016-09-24
00827002218604	Soehendra	COOK INCORPORATED	LQC	2016-09-24
00827002254725	Conquest TTC	COOK INCORPORATED	LQC	2016-09-24
00827002255180	Conquest TTC	COOK INCORPORATED	LQC	2016-09-24
04048551079478	n.a.	Karl Storz GmbH & Co. KG	LQC	2016-09-23
04953170032745	Basket Wire	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170032769	Basket Wire	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170032875	Basket Wire	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170032981	Basket Wire	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170033070	DISPOSABLE MECHANICAL LITHOTRIPTOR	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170218347	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21
04953170218361	Single Use Mechanical Lithotriptor V	OLYMPUS MEDICAL SYSTEMS CORP.	LQC	2016-09-21

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K040447	LQC	TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088	Boston Scientific Corp	2004-03-12
510(k)	K011178	LQC	WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR	Wilson-Cook Medical, Inc.	2001-05-04
510(k)	K964937	LQC	A LITHOTRIPTER-COMPATIBLE BASKET	Boston Scientific Corp	1997-01-24
510(k)	K942544	LQC	GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS	Medi-Globe Corp.	1994-11-22
510(k)	K943191	LQC	MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR	Boston Scientific Corp	1994-08-29

MAUDE MDR 9847434

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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Related PMN/PMA Records By Product Code#