TPLC - Total Product Life Cycle

• Device: accessories,arthroscopic
• Regulation Description: Arthroscope.
• Product Code: NBH
• Regulation Number: 888.1100
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
UTAH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	46
Tip breakage	22
Device, or device fragments remain in patient	20
Material fragmentation	16
Unknown (for use when the device problem is not known)	16
Device Issue	7
No Known Device Problem	6
Foreign material	5
Metal shedding debris	2
Difficult to remove	1
Material separation	1
Membrane leak(s)	1
Premature system activation	1
Shock, electrical	1
Cut in material	1
Total Device Problems	146

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

Recalls
Manufacturer		Recall Class	Date Posted
1	DePuy Mitek, Inc., a Johnson & Johnson Co.	II	May-09-2013
2	Instratek, Incorporated	II	Mar-08-2013
3	Integra LifeSciences Corp.	II	Mar-19-2012
4	Smith & Nephew, Inc Endoscopy Division	III	Jun-06-2007
5	Smith & Nephew, Inc. Endoscopy Division	II	Oct-12-2010
6	Smith & Nephew, Inc. Endoscopy Division	II	Jul-14-2009
7	Smith & Nephew, Inc., Endoscopy Div.	II	Nov-24-2009
8	TAG Medical Corp.	II	Jan-19-2010