TPLC - Total Product Life Cycle

• Device: laryngoscope, endoscope
• Regulation Description: Endoscope and accessories.
• Product Code: GCI
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COMPUTER MOTIO
	SUBSTANTIALLY EQUIVALENT	1
CONMED
	SUBSTANTIALLY EQUIVALENT	2
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
NORTHGATE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	55
Torn material	52
Optical issue	40
Detachment of device component	30
Detachment of device or device component	28
Material separation	13
Material rupture	12
Failure to conduct	11
Difficult to remove	5
Difficult to open or close	5
Charging issue	5
Hole in material	3
Burst	2
Device Cleaning Issue	2
Mechanical issue	2
Fitting problem	2
Material perforation	2
Connection issue	2
Device markings issue	2
Failure to separate	2
Device or device fragments location unknown	1
Improper or incorrect procedure or method	1
Material deformation	1
No Known Device Problem	1
Power source issue	1
No Information	1
Device damaged prior to use	1
Component missing	1
Out-of-box failure	1
Material puncture	1
Failure to charge	1
Difficult to insert	1
Crack	1
Difficult to deploy	1
Material fragmentation	1
Total Device Problems	290

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	0	0	0
Class II	0	0	0	0	0	0	0	0	1	0	0
Class III	0	0	0	0	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	EXP Pharmaceutical Services Corp	II	Jul-24-2015