MAUDE MDR 9104073

MDR report key: 9104073
Report number: 2951238-2019-01126
Event key: 0
Event type: 3
Date of event: 2019-08-26
Date received: 2019-09-23
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: MS. CONNIE TUBERA
Address: 2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone: 408-408-4089
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	ROTATING CF RESECTOSCOPE INNER SHEATH	RESECTION INNER SHEATH	GYRUS ACMI, INC	FAS	ERIS-CF25		GA				Y	R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-09-23	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
08904148106339	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-05-03
08904148106353	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-05-03
08904148101402	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101525	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101570	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101587	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101600	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101617	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101624	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101822	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101839	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101846	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101853	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101860	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101877	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148101891	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148102157	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148102164	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148102379	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148103628	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148105868	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148105875	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148105882	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148106322	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
08904148106346	ACE	ACE MEDICAL DEVICES PRIVATE LIMITED	FAS	2025-04-28
10801334004347	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	FAS	2019-01-21
10801334003883	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	FAS	2018-12-03
10801334004828	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	FAS	2017-05-09
10801334000707	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	FAS	2017-05-03
10801334001124	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	FAS	2017-05-03

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K251403	FAS	Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )	Dornier Medtech America Inc (Dmta)	2025-12-05
510(k)	K250522	FAS	Multi4 System	Multi4 Medical AB	2025-06-27
510(k)	K240504	FAS	PLASMA EDGE System	Lamidey Noury Medical	2024-06-12
510(k)	K213135	FAS	Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge	Chirurgie Innovation	2022-03-02
510(k)	K210651	FAS	Resection Electrodes with HF cable	Olympus Winter & Ibe GmbH	2021-08-03

MAUDE MDR 9104073

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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