TPLC - Total Product Life Cycle

• Device: lamp, surgical
• Regulation Description: Surgical lamp.
• Product Code: FTD
• Regulation Number: 878.4580
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ATRICURE, INC.
	SUBSTANTIALLY EQUIVALENT	2
BURTON MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL ILLUMINATION
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	3
WARNER-LAMBERT CO.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Detachment of device component	31
Component falling	16
Mechanical issue	6
Component(s), broken	5
Other (for use when an appropriate device code cannot be identified)	3
Component missing	2
Break	2
Material fragmentation	2
Handpiece break	2
Device maintenance issue	2
Melted	1
Difficult to position	1
Smoking	1
Device inoperable	1
Heat	1
Charred	1
Component(s), worn	1
Electrical issue	1
Unintended ejection	1
Fire	1
Device displays error message	1
Detachment of device or device component	1
Device or device component damaged by another device	1
Dislodged or dislocated	1
Environmental control or utility issue	1
Temperature issue	1
Total Device Problems	87

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	4	2	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Berchtold Corp.	II	Dec-10-2010
2	Draeger Medical, Inc.	II	Sep-16-2009
3	MAQUET Inc.	II	Nov-12-2009
4	MAQUET Inc.	II	Apr-12-2009
5	Skytron, Div. The KMW Group, Inc	II	Feb-22-2007
6	Steris Corp	II	Nov-23-2009
7	Steris Corporation	II	Apr-01-2010