TPLC - Total Product Life Cycle

• Device: trocar
• Regulation Description: Trocar.
• Product Code: DRC
• Regulation Number: 870.1390
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	2
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANSEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HEARTPORT, INC.
	SUBSTANTIALLY EQUIVALENT	2
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DEVICE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSCOR, INC.
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
STERILMED
	SUBSTANTIALLY EQUIVALENT	1
THOMAS MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	57
Detachment of device component	18
Break	9
Leak	5
Component(s), broken	3
Physical resistance	3
Device, or device fragments remain in patient	2
Air leak	2
Bent	1
Method, improper/incorrect	1
Crack	1
Difficult to insert	1
Difficult to remove	1
Tip breakage	1
Unknown (for use when the device problem is not known)	1
Material perforation	1
Device Issue	1
Device operational issue	1
Scratched material	1
Temperature issue	1
Total Device Problems	111

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	1	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Medical Device Technologies, Inc.	II	Jul-13-2010