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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical, cutting & coagulation & accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeGEI
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 5
A&E
  SUBSTANTIALLY EQUIVALENT 6
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 27
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 15
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALPHA SOURCE, INC
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN BIOSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 8
ARAGON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 73
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 26
ASPEN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 4
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BARRX MEDICAL, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 15
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
BEI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLACK & BLACK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 16
BOVIE
  SUBSTANTIALLY EQUIVALENT 8
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 11
CAMERON-MILLER, INC.
  SUBSTANTIALLY EQUIVALENT 10
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CELON AG MEDICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 60
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 12
CRYOGEN, INC.
  SE - WITH LIMITATIONS 1
CURON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 7
DEROYAL
  SUBSTANTIALLY EQUIVALENT 3
ELECTROMEDICS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 20
ELMED
  SUBSTANTIALLY EQUIVALENT 6
EMCISION, LTD.
  SUBSTANTIALLY EQUIVALENT 6
ENCISION, INC.
  SUBSTANTIALLY EQUIVALENT 8
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDYMION MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
ENERGIST, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 28
ETHICON
  SUBSTANTIALLY EQUIVALENT 24
FUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GENICON
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 3
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 28
HALT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INVASIX LTD.
  SUBSTANTIALLY EQUIVALENT 1
ION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ISKRA MEDICAL, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 13
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 10
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 3
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 5
LINEMASTER SWITCH CORP.
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 6
LIVE TISSUE CONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 4
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDISISS
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 29
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 7
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 4
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 8
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NCONTACT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIX CORP.
  SUBSTANTIALLY EQUIVALENT 3
NEOTHERMIA
  SUBSTANTIALLY EQUIVALENT 6
NEW DEANTRONICS TAIWAN, LTD.
  SUBSTANTIALLY EQUIVALENT 8
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
OLSEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 13
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 3
PATTON SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PEAK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 2
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO-MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
Q2 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RADIOTHERAPEUTICS
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 9
RHYTEC
  SUBSTANTIALLY EQUIVALENT 5
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 11
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 14
RUBICOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
RUDOLF STORZ GMBH
  SUBSTANTIALLY EQUIVALENT 1
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SALIENT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 31
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 4
SOMNUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 16
SORIN
  SUBSTANTIALLY EQUIVALENT 1
STARION INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 6
STELLARTECH RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 11
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
STINGRAY SURGICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 19
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SURGRX, INC.
  SUBSTANTIALLY EQUIVALENT 8
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 3
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 5
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNERON
  SUBSTANTIALLY EQUIVALENT 4
TECNO INSTRUMENTS (PVT.) LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
THERMAGE, INC.
  SUBSTANTIALLY EQUIVALENT 17
THERMOSURGERY TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TISSUELINK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 12
TRANSAMERICAN TECHNOLOGIES INTL.
  SUBSTANTIALLY EQUIVALENT 1
TROD MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
UROLOGIX
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 71
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIDAMED, INC.
  SUBSTANTIALLY EQUIVALENT 7
VNUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Break 2339
Device displays error message 522
No Known Device Problem 431
Unknown (for use when the device problem is not known) 403
Detachment of device component 394
Other (for use when an appropriate device code cannot be identified) 353
Device operates differently than expected 323
Tip breakage 292
Replace 239
Device inoperable 222
Peeled 214
Failure to deliver energy 203
Device remains activated 192
Electrical issue 175
No Information 166
Detachment of device or device component 151
Component(s), broken 146
Bent 139
Device Issue 124
Difficult to open or close 119
Melted 116
Burn of device or device component 104
Mechanical issue 100
Spark 99
Self-activation or keying 86
Material deformation 80
No code available 79
Burst 77
Dislodged or dislocated 74
Crack 70
Failure to cut 67
Inflation issue 64
Sticking 61
Component(s), overheating of 60
Component falling 59
Material fragmentation 59
Overheating of device or device component 54
Smoking 54
Arcing 54
Retraction problem 47
Intermittent continuity 47
Material separation 46
Fire 45
Fracture 42
Therapeutic or diagnostic output failure 42
Mechanical jam 38
Environmental Particulates 38
Device stops intermittently 38
Leak 37
Use of Device Issue 33
Arcing at electrodes 33
Improper flow or infusion 32
Loss of or failure to bond 28
Output issue 27
Component missing 27
Not Applicable 25
Loss of power 23
Difficult to remove 22
Temperature issue 22
Material integrity issue 21
Foreign material present in device 21
Failure to Adhere or Bond 20
Improper or incorrect procedure or method 18
System fails to activate 18
Failure to conduct 17
Charred 16
Image resolution poor 16
Energy output to patient tissue incorrect 16
Device or device fragments location unknown 16
Malfunction 16
Device, removal of (non-implant) 15
Noise, Audible 15
Difficult or delayed activation 14
Noise 14
Defective item 13
Loose or intermittent connection 13
Biofilm coating in device 13
Balloon burst 12
Failure to separate 12
Physical resistance 11
Defective component 11
Torn material 11
Device packaging compromised 11
Alarm, error of warning 11
Error or warning message, failure to produce 11
Failure to power-up 11
No device output 11
Electronic property issue 10
Dull 10
Failure to align 10
Failure to fire 9
Tears, rips, holes in device, device material 8
Device, or device fragments remain in patient 8
No display or display failure 8
Device alarm system issue 8
Alarm, audible 7
Blockage within device or device component 7
Entrapment of device or device component 7
Degraded 7
Material discolored 7
Total Device Problems 9766

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 7 10 8 15 15 21 16 13 11 2
Class III 0 0 1 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Dec-11-2013
2 Aesculap, Inc. II Feb-26-2013
3 Alcon Research, Ltd. II Dec-12-2014
4 Angiodynamics II Feb-24-2015
5 Angiodynamics, INC II Jul-10-2013
6 Angiodynamics, INC II Aug-24-2011
7 Applied Medical Resources Corp II Sep-15-2015
8 ArthroCare Corporation II Apr-05-2016
9 ArthroCare Corporation II Jan-08-2016
10 ArthroCare Corporation II Jul-18-2015
11 ArthroCare Corporation II Aug-30-2009
12 ArthroCare Corporation II Sep-19-2008
13 ArthroCare Medical Corporation II Jun-25-2015
14 ArthroCare Medical Corporation II Mar-26-2015
15 ArthroCare Medical Corporation II Dec-16-2014
16 Barrx Medical, Inc. II Jul-06-2011
17 Barrx Medical, Inc. II Oct-31-2008
18 Boston Scientific Corp II Sep-09-2009
19 Boston Scientific Corp II Sep-16-2008
20 Boston Scientific Corp II Sep-11-2008
21 Boston Scientific Corporation II Oct-18-2012
22 Boston Scientific Corporation III Mar-28-2012
23 Cambridge Endoscopic Devices, Incorporated II Jul-06-2011
24 Centurion Medical Products II May-12-2010
25 ConMed Corporation II Dec-01-2015
26 ConMed Corporation II Nov-03-2015
27 ConMed Corporation II Jun-20-2014
28 ConMed Corporation II Jun-04-2014
29 ConMed Corporation II Nov-15-2013
30 ConMed Corporation II Feb-15-2013
31 ConMed Corporation II Jan-24-2013
32 ConMed Electrosurgery II May-29-2012
33 ConMed Electrosurgery II May-29-2012
34 ConMed Electrosurgery II Feb-17-2011
35 ConMed Electrosurgery II Aug-25-2010
36 ConMed Electrosurgery II May-10-2010
37 ConMed Electrosurgery II Nov-10-2009
38 ConMed Electrosurgery II Dec-11-2007
39 ConvaTec II Mar-16-2010
40 Covidien LLC II Sep-14-2012
41 Covidien LP II Jan-25-2011
42 Covidien, PLC II Jan-11-2012
43 Covidien, PLC II Aug-30-2011
44 Datascope Corporation II Aug-09-2007
45 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-23-2015
46 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-24-2012
47 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-27-2010
48 EXP Pharmaceutical Services Corp II Jul-24-2015
49 Ellman International, Inc. II May-17-2012
50 Encision, Inc. II Jul-06-2012
51 Encision, Inc. II Aug-30-2011
52 Encision, Inc. II May-31-2011
53 Encision, Inc. II May-06-2010
54 Ethicon Endo-Surgery Inc II Jan-31-2013
55 Ethicon Endo-Surgery Inc II Mar-21-2012
56 Ethicon Endo-Surgery Inc II Feb-15-2011
57 Gyrus ACMI Corporation II Jan-14-2010
58 Gyrus ACMI Corporation II Nov-05-2008
59 Gyrus Acmi, Incorporated II Jun-11-2015
60 Gyrus Acmi, Incorporated II Sep-30-2010
61 Gyrus Medical, Inc II Oct-21-2014
62 Gyrus Medical, Inc II Aug-19-2013
63 Hemostatix Medical Technologies LLC II Sep-28-2010
64 Innovatech Medical Resources L.P. II Jan-11-2012
65 Instrumed International, Inc. II Sep-30-2014
66 Kentucky Packaging Service LP II Nov-10-2009
67 Linvatec Corp. dba ConMed Linvatec II Sep-09-2009
68 Maquet Cardiovascular, LLC II Dec-06-2013
69 Maquet Cardiovascular, LLC II Sep-20-2011
70 Medtronic Advanced Energy, LLC II Jan-31-2014
71 Medtronic Cardiac Surgery Technologies II Feb-02-2008
72 Medtronic Neuromodulation II Apr-02-2013
73 Megadyne Medical Products, Inc. II Mar-07-2014
74 Megadyne Medical Products, Inc. II Aug-27-2013
75 Megadyne Medical Products, Inc. III Dec-03-2009
76 Microline Surgical II May-20-2014
77 Microline Surgical, Inc. II Jul-02-2014
78 Microline Surgical, Inc. II Aug-29-2011
79 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Aug-29-2012
80 Olympus America Inc. II Dec-05-2013
81 Olympus America Inc. II Jan-13-2012
82 PSC Industries Inc II Jul-12-2012
83 PSC Industries Inc II Jul-11-2012
84 Peak Surgical II Feb-02-2011
85 Plasma Surgical Inc. II Jun-11-2012
86 Progressive Medical Inc II May-22-2013
87 Rhytec Inc. II Feb-01-2007
88 Rita Medical Systems, Inc. II Apr-19-2007
89 Smith & Nephew, Inc. Endoscopy Division II Aug-03-2012
90 Smith & Nephew, Inc. Endoscopy Division II Jan-11-2012
91 Sorin Group USA, Inc. II Jan-14-2010
92 Sound Surgical Technologies, LLC II Jan-25-2011
93 Sound Surgical Technologies, LLC II Mar-13-2008
94 Starion Instruments II Aug-19-2010
95 Starion Instruments II Jul-09-2010
96 Starion Instruments II Jul-08-2010
97 Sterilmed Inc II Jan-13-2009
98 Stingray Surgical Products, LLC II Jul-13-2012
99 Stryker Endoscopy II Jun-24-2015
100 Stryker Endoscopy II May-02-2014
101 Stryker Endoscopy II Jul-09-2012
102 Stryker Endoscopy II Nov-21-2011
103 Stryker Endoscopy II Mar-17-2011
104 Stryker Endoscopy II Aug-09-2010
105 Stryker Endoscopy II Feb-09-2009
106 Stryker Endoscopy II Mar-05-2008
107 Stryker Endoscopy II Jan-17-2008
108 Stryker Sustainability Solutions, Inc. II Mar-13-2012
109 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
110 Telefelx Medical II Sep-27-2010
111 Teleflex Medical II Jan-15-2014
112 The Anspach Effort, Inc. II Jun-25-2014
113 Unimed Surgical Products, Inc. II May-22-2013
114 Unimed Surgical Products, Inc. II Aug-28-2012
115 Unimed Surgical Products, Inc. II Oct-21-2009
116 Urologix, Inc. II Nov-08-2013
117 VNUS Medical Technologies Inc II Jan-24-2008
118 VNUS Medical Technologies Inc II Dec-15-2007
119 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Nov-07-2007
120 Zinnanti Surgical Design LLC II Aug-14-2007

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