FILSHIE * AVM-851

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-02 for FILSHIE * AVM-851 manufactured by Coopersurgical Inc..

Event Text Entries

[3422799] The pt had a low-transverse c-section performed. The filshie clips were used for a tubal ligation. After the closure of the surgical wound, a small amount of oozing was noted at the incision site. Three small areas were cauterized using mono-polar energy. Pt recovered and was discharge home. Four days after procedure the pt required surgery due to perforated colon. Pt had three small perforations of the colon. Pt's primary physician felt that the perfs were related to the positioning of the filshie clips and that they redirected or caused a deflection of the electrical energy causing the injury to the colon. ======================manufacturer response for filshie ligation clip, filshie clip (per site reporter). ======================the company representative reports that the product is made of titanium and medical grade silicone (not steel) and is a poor conductor of radio frequency. They have not received any reports of similar events. They will trend. What was the original intended procedure? Post partum sterilization post low-transverse c-section with cauterization of bleeding vessels after surgical incision closure. Device #1is this a laboratory device or laboratory test? No. Device #2is this a laboratory device or laboratory test? No. Device #3is this a laboratory device or laboratory test? No. Device #4is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3098998
MDR Report Key	3098998
Date Received	2013-05-02
Date of Report	2013-05-02
Date of Event	2013-04-02
Report Date	2013-05-02
Date Reported to FDA	2013-05-02
Date Reported to Mfgr	2013-05-08
Date Added to Maude	2013-05-08
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	FILSHIE
Generic Name	CLIP, TUBAL OCCLUSION
Product Code	HGB
Date Received	2013-05-02
Model Number	*
Catalog Number	AVM-851
Lot Number	32871 OR 28903
ID Number	*
Operator	PHYSICIAN
Device Availability	N
Device Age	1 DY
Device Sequence No	1
Device Event Key	0
Manufacturer	COOPERSURGICAL INC.
Manufacturer Address	95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611

Device Sequence Number: 2

Brand Name	FORCE FX
Generic Name	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product Code	GEI
Date Received	2013-05-02
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	Y
Device Age	*
Device Sequence No	2
Device Event Key	0
Manufacturer	VALLEYLAB INC.
Manufacturer Address	5920 LONGBOW DR. BOULDER CO 80301 US 80301

Device Sequence Number: 3

Brand Name	MEGA2000
Generic Name	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Product Code	GEI
Date Received	2013-05-02
Model Number	*
Catalog Number	0800
Lot Number	*
ID Number	*
Device Availability	*
Device Age	*
Device Sequence No	3
Device Event Key	0
Manufacturer	MEGADYNE MEDICAL PRODUCTS INC.
Manufacturer Address	11506 SOUTH STATE STREET DRAPER UT 84020 US 84020

Device Sequence Number: 4

Brand Name	MINILAPOROTOMY FILSHIE APPLICATOR
Generic Name	CLIP, TUBAL OCCLUSION
Product Code	HGB
Date Received	2013-05-02
Model Number	*
Catalog Number	AVM-856
Lot Number	*
ID Number	*
Device Availability	Y
Device Age	1 YR
Device Sequence No	4
Device Event Key	0
Manufacturer	COOPERSURGICAL INC.
Manufacturer Address	95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2013-05-02