TPLC - Total Product Life Cycle

• Device: unit, electrosurgical, endoscopic (with or without accessories)
• Regulation Description: Endoscopic electrosurgical unit and accessories.
• Product Code: KNS
• Regulation Number: 876.4300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AARON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
APOLLO CORP.
	SUBSTANTIALLY EQUIVALENT	1
ARGOMED
	SUBSTANTIALLY EQUIVALENT	2
ARTHROCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BALLARD MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BIOSEARCH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	13
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
CAMERON-MILLER, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONMED
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
EMCISION, LTD.
	SUBSTANTIALLY EQUIVALENT	2
ETHICON
	SUBSTANTIALLY EQUIVALENT	1
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	4
HOGAN & HARTSON L.L.P.
	SUBSTANTIALLY EQUIVALENT	2
INTERNATIONAL MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	5
REDFIELD CORP.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
VIDAMED, INC.
	SUBSTANTIALLY EQUIVALENT	4
WILSON COOK MEDICAL
	SUBSTANTIALLY EQUIVALENT	9

Device Problems
Other (for use when an appropriate device code cannot be identified)	323
Break	318
Failure to deliver energy	239
Retraction problem	193
Electrical issue	182
Bent	138
Component(s), broken	133
Wire(s), breakage of	129
No code available	87
Tip breakage	77
Detachment of device component	76
Output issue	73
Kinked	71
Cautery	68
Split	66
Failure to cut	53
Melted	45
Device inoperable	44
Twisting	43
Material frayed	39
Detachment of device or device component	36
No Known Device Problem	33
Pumping issue	32
Failure, intermittent	30
Device displays error message	29
Peeled	29
No device output	29
Unknown (for use when the device problem is not known)	28
Failure to advance	27
Failure to conduct	27
Loose or intermittent connection	27
Output energy incorrect	23
Device damaged prior to use	22
Crack	22
Failure to align	21
Heat, failure to	20
Device Issue	20
Torn material	16
Malfunction	15
Not audible alarm	14
Tears, rips, holes in device, device material	13
Device, or device fragments remain in patient	13
Device alarm system issue	13
Arcing	12
Fracture	12
Failure to deploy	12
Defective item	12
Source, detachment from	12
Handpiece break	11
Flaked	11
No Information	10
Output, low	10
Difficult to remove	10
Energy output to patient tissue incorrect	9
Device operates differently than expected	9
Low audible alarm	8
Normal	8
Foreign material present in device	7
Defective component	7
Inability to irrigate	7
Difficult to deploy	7
Physical resistance	7
Endoscopic accessory fire or melt	7
Material separation	6
Out-of-box failure	6
Probe failure	6
Failure to power-up	6
Failure to pump	6
Smoking	6
Dislodged or dislocated	6
Pumping stopped	6
Difficult to insert	6
Leak	6
Needle, separation	6
Unintended movement	5
Shock, electrical	5
Sharp/jagged/rough/etched/scratched	5
Fitting problem	5
Footswitch failure	5
Drift	4
Loss of power	4
Spark	4
Fire	4
Cable break	4
Insulation, hole(s) in	4
Decreased pump speed	4
Material perforation	4
Incorrect display	4
Inappropriate shock	4
Needle, unsheathed	4
Cable, defective	4
Burn of device or device component	3
Replace	3
Device or device fragments location unknown	3
Device Difficult to Setup or Prepare	3
Difficult to position	3
Disassembly	3
Foreign material	3
Steering wire problem	3
Hole in material	3
Total Device Problems	3290

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Feb-13-2009
2	Cook Endoscopy	III	Jul-21-2009
3	Cook Endoscopy	III	Mar-10-2009
4	Cook Endoscopy	II	Jan-05-2009
5	Gyrus ACMI Corporation	II	Mar-13-2007
6	Medtronic Neuromodulation	II	Mar-10-2009
7	Olympus America Inc.	II	May-08-2013
8	Olympus America Inc.	II	Jan-20-2012