TPLC - Total Product Life Cycle

• Device: electrode, ph, stomach
• Regulation Description: Stomach pH electrode.
• Product Code: FFT
• Regulation Number: 876.1400
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BIOSEARCH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
DATEX-OHMEDA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR TECHNOLOGY INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Failure to deploy	659
Other (for use when an appropriate device code cannot be identified)	612
Handpiece break	123
Unknown (for use when the device problem is not known)	68
Failure to advance	65
Difficult to deploy	4
Premature deployment	4
Device Issue	4
Implant, removal of	3
Explanted	3
Difficult to position	3
Calibration error	3
Improper or incorrect procedure or method	3
Device, removal of (non-implant)	2
Malfunction	2
Trocar failure	2
Device, or device fragments remain in patient	2
Difficult to remove	1
Spring loading mechanism problem	1
Air leak	1
Bent	1
Foreign material	1
Failure to power-up	1
Probe failure	1
Device remains implanted	1
Break	1
No display or display failure	1
Material perforation	1
Component missing	1
Device or device fragments location unknown	1
Reuse	1
Suction issue	1
Invalid sensing	1
Failure to transmit record	1
Replace	1
Device contamination with blood or blood product	1
Unexpected therapeutic results	1
Total Device Problems	1582

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Neuromodulation	II	May-07-2008