TPLC - Total Product Life Cycle

• Device: laparoscope, general & plastic surgery
• Regulation Description: Endoscope and accessories.
• Product Code: GCJ
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
ACKERMANN INSTRUMENTE GMBH
	SUBSTANTIALLY EQUIVALENT	1
ACMI CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP
	SUBSTANTIALLY EQUIVALENT	12
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANCHOR PRODUCTS CO.
	SUBSTANTIALLY EQUIVALENT	3
APPLE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	22
APPLITEC, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ARTHROTEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAITELLA AG
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	5
BIOSEARCH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	6
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	12
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	4
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMPUTER MOTIO
	SUBSTANTIALLY EQUIVALENT	21
CONMED
	SUBSTANTIALLY EQUIVALENT	17
CONTOUR FABRICATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	8
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	4
DEROYAL
	SUBSTANTIALLY EQUIVALENT	1
Eagle
	SUBSTANTIALLY EQUIVALENT	1
EASTMAN KODAK
	SUBSTANTIALLY EQUIVALENT	1
ENCISION, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCONTROL
	SUBSTANTIALLY EQUIVALENT	1
ETHICON
	SUBSTANTIALLY EQUIVALENT	50
EZSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
GENICON
	SUBSTANTIALLY EQUIVALENT	4
GENZYME CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	5
HAAKO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
HEARTPORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
HENKE SASS WOLF
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
I.C. MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INLET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
INNOVIA, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA
	SUBSTANTIALLY EQUIVALENT	1
INTERLACE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
INTUITIVE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
J. JAMNER
	SUBSTANTIALLY EQUIVALENT	3
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	48
KENSEY NASH CORP.
	SUBSTANTIALLY EQUIVALENT	2
KINETIC SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
KLS MARTIN GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LINVATEC
	SUBSTANTIALLY EQUIVALENT	4
LSI SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	3
LUMENIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MAQUET, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAUNA KEA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
MECTRA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDAFOR, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	5
MEDSYS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MENTOR CORP.
	SUBSTANTIALLY EQUIVALENT	1
MICROLINE PENTAX, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICROMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
MINI LAP TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NORTHGATE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
NOVADAQ TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVARE SURGICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	15
ONYX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
OPTISCAN PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
OPTUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PAJUNK GMBH
	SUBSTANTIALLY EQUIVALENT	6
PATTON SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
PENTAX
	SUBSTANTIALLY EQUIVALENT	2
PILLING WECK
	SUBSTANTIALLY EQUIVALENT	1
POINTE CONCEPTION MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF
	SUBSTANTIALLY EQUIVALENT	29
SCANLAN
	SUBSTANTIALLY EQUIVALENT	1
SHIPPERT MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	13
SOLOS ENDOSCOPY, INC
	SUBSTANTIALLY EQUIVALENT	1
SOPRO
	SUBSTANTIALLY EQUIVALENT	13
SPEMBLY CRYOSURGERY
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	15
SURGICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGIQUEST, INC.
	SUBSTANTIALLY EQUIVALENT	5
SUTURA, INC.
	SUBSTANTIALLY EQUIVALENT	1
Symbiosis Corp.
	SUBSTANTIALLY EQUIVALENT	4
T. KOROS SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
TAUT
	SUBSTANTIALLY EQUIVALENT	5
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	5
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
TRANSAMERICAN TECHNOLOGIES INTL.
	SUBSTANTIALLY EQUIVALENT	1
TRINITY
	SUBSTANTIALLY EQUIVALENT	1
TROKAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	36
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
VIRTUAL PORTS LTD
	SUBSTANTIALLY EQUIVALENT	2
VISIONSENSE, LTD.
	SUBSTANTIALLY EQUIVALENT	2
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	2
W.O.M. GMBH
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Detachment of device component	283
Break	245
Air leak	196
Optical distortion	182
Replace	174
Leak	147
Tears, rips, holes in device, device material	143
Gas leak	143
Other (for use when an appropriate device code cannot be identified)	111
Material fragmentation	65
Device Issue	57
Image resolution poor	56
Torn material	51
Device operates differently than expected	43
Dislodged or dislocated	35
Tip breakage	35
Unknown (for use when the device problem is not known)	34
Inflation issue	32
Component falling	32
Mechanical issue	29
Component(s), broken	28
Crack	27
Device, or device fragments remain in patient	25
Device maintenance issue	21
Device inoperable	20
Fracture	19
Electrical power problem	18
Component missing	18
Bent	17
Material separation	17
Burst	16
Device operational issue	16
Device, removal of (non-implant)	16
Fitting problem	15
Failure to cut	15
Fluid leak	15
Difficult to insert	15
Malfunction	14
Decrease in pressure	12
Valve(s), failure of	12
Sticking	11
Material perforation	11
Use of Device Issue	11
Device damaged prior to use	11
Failure to form staple	11
Failure to deploy	10
Out-of-box failure	10
Balloon burst	10
Image display error	10
Seal, defective	9
Retraction problem	9
Balloon rupture	9
No Information	9
Mechanical jam	9
No Known Device Problem	9
Difficult to remove	8
Foreign material	8
No code available	8
Particulates	8
No display or display failure	8
Tear, rip or hole in device packaging	8
Poor quality image	8
Optical issue	7
Device or device fragments location unknown	7
Slippage of device or device component	7
Failure to deliver energy	7
Difficult to open or close	6
Failure to advance	6
Size incorrect for patient	6
Normal	6
Failure to fire	5
Split	5
Coagulation in device or device ingredient	5
Loose or intermittent connection	5
Difficult to advance	5
Misfire	5
Electrical issue	4
Repair	4
Hole in material	4
Melted	4
Improper or incorrect procedure or method	4
Elective removal	4
Loose	3
Peeled	3
Dislodged	3
Material deformation	3
Material integrity issue	3
Material puncture	3
Disassembly	3
Cut in material	3
Structural problem	3
Implant extrusion	3
Unsealed device packaging	3
Lubrication	3
Pressure, insufficient	3
Increase in pressure	2
Device displays error message	2
Locking mechanism failure	2
Membrane tear(s)	2
Material rupture	2
Total Device Problems	2809

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	1
Class II	2	4	2	8	10	2	0
Class III	0	3	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Anchor Products Company, Inc.	II	Mar-07-2011
2	Applied Medical Resources Corp	II	Aug-24-2011
3	Applied Medical Resources Corp	II	Aug-10-2011
4	Applied Medical Resources Corp	II	Mar-03-2011
5	Applied Medical Resources Corp	II	Sep-18-2009
6	Applied Medical Resources Corp	II	Oct-07-2008
7	CTS, Inc. dba Guidant Cardiac Surgery	II	Dec-13-2010
8	CTS, Inc. dba Guidant Cardiac Surgery	II	Dec-23-2008
9	Conmed Corporation	II	Feb-02-2008
10	Conmed Corporation	II	Mar-13-2007
11	Continental Medical Labs,Inc	II	Jan-18-2007
12	Ethicon Endo-Surgery Inc	II	Jan-27-2009
13	Gyrus Acmi, Incorporated	II	Sep-19-2010
14	Lumenis Limited	I	Feb-14-2013
15	Olympus America Inc.	II	Oct-01-2010
16	Smith & Nephew, Inc. Endoscopy Division	II	May-01-2012
17	Smith & Nephew, Inc. Endoscopy Division	II	Oct-21-2011
18	Stryker Communications	III	Jan-12-2008
19	Stryker Communications Corp	II	Oct-28-2011
20	Stryker Communications Corp	II	Jun-15-2010
21	Stryker Communications Corp	II	May-21-2010
22	Stryker Communications Corp	III	Sep-29-2008
23	Stryker Endoscopy	II	Jan-19-2011
24	Stryker Endoscopy	II	Sep-29-2010
25	Stryker Endoscopy	III	Oct-24-2008
26	Stryker Endoscopy	II	Aug-24-2008
27	Teleflex Medical	II	Jun-23-2010
28	Terumo Cardiovascular Systems Corporation	II	Jul-21-2011
29	Terumo Cardiovascular Systems Corporation	II	Feb-14-2011
30	Transenterix, INC	II	Sep-22-2010
31	Transenterix, Inc	II	Aug-03-2012
32	Transenterix, Inc	II	Apr-08-2011