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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.
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeGEI
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
AGNES MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 5
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BAISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BIPAD SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOLDER SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
BOLDER SURGICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BOVIE MEDICAL CORPORATION DBA APYX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOWA-ELECTRONICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BTL
  SUBSTANTIALLY EQUIVALENT 3
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 2
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBRIDGE INTERVENTIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC
  SUBSTANTIALLY EQUIVALENT 1
CARTESSA AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
CATHAY MANFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 4
CYNOSURE, INC
  SUBSTANTIALLY EQUIVALENT 3
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
DANNIK LLC
  SUBSTANTIALLY EQUIVALENT 2
DEX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELLUSA, LLC
  SUBSTANTIALLY EQUIVALENT 2
ENCISION INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCISION INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 7
FAULHABER PINZETTEN OHG
  SUBSTANTIALLY EQUIVALENT 1
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 1
FULWELL LLC
  SUBSTANTIALLY EQUIVALENT 2
GENICON, INC
  SUBSTANTIALLY EQUIVALENT 1
GENICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETSCH+HILLER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GOWOONSESANG COSMETICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
GUNTER BISSINGER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HS HOSPITAL SERVICE SPA
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 2
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 5
INNOBLATIVE DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA MICROFRANCE
  SUBSTANTIALLY EQUIVALENT 1
INTELIS INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVUITY INC.
  SUBSTANTIALLY EQUIVALENT 1
JAC-CELL MEDIC
  SUBSTANTIALLY EQUIVALENT 1
JACO, LLC DBA MACAN MANUFACTURING AND BNA BURZ NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 4
LUMENDI, LLC
  SUBSTANTIALLY EQUIVALENT 2
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDRANGE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEAUVIA NORTH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 2
NEURENT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NEW DEANTRONICS TAIWAN, LTD
  SUBSTANTIALLY EQUIVALENT 1
NEW DEANTRONICS TAIWAN LTD
  SUBSTANTIALLY EQUIVALENT 7
NEW DEANTRONICS TAIWAN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NICO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NISSHA MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVOXEL LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 5
PAVMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PULSE BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 4
RELIGN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RF MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENB CO LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENB CO LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SONIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 3
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL DIRECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL TECHNOLOGY LABORATORIES, INC
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURNIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 4
SYNERON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERMGEN, L.L.C
  SUBSTANTIALLY EQUIVALENT 1
THERMI
  SUBSTANTIALLY EQUIVALENT 1
THERMIGEN, L.L.C
  SUBSTANTIALLY EQUIVALENT 1
TITAN MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIWORKS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
US ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VENCLOSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 3
VIOL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
VIVEVE INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVEVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VIVEVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 6068 6068
2018 6539 6539
2019 7065 7065
2020 6490 6490
2021 6329 6329

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6103 6103
Adverse Event Without Identified Device or Use Problem 3004 3004
Energy Output Problem 1751 1751
Difficult to Open or Close 1443 1443
Detachment of Device or Device Component 1200 1200
Peeled/Delaminated 1043 1043
Insufficient Information 726 726
Detachment Of Device Component 697 697
Self-Activation or Keying 670 670
Energy Output To Patient Tissue Incorrect 665 665
Fire 649 649
Electrical /Electronic Property Problem 635 635
Sparking 603 603
Output Problem 601 601
Material Separation 596 596
Delivered as Unsterile Product 558 558
Melted 545 545
Device Operates Differently Than Expected 484 484
Failure to Deliver Energy 483 483
Protective Measures Problem 476 476
Retraction Problem 466 466
Device Displays Incorrect Message 455 455
Mechanical Problem 435 435
Material Fragmentation 417 417
Failure to Cut 403 403
Mechanical Jam 377 377
Material Twisted/Bent 375 375
Overheating of Device 361 361
Activation Problem 337 337
Smoking 333 333
Use of Device Problem 329 329
Temperature Problem 310 310
Arcing 302 302
Device Remains Activated 284 284
Suction Failure 284 284
Defective Device 277 277
Connection Problem 256 256
Infusion or Flow Problem 244 244
Material Integrity Problem 240 240
Device Alarm System 217 217
Thermal Decomposition of Device 214 214
No Apparent Adverse Event 214 214
Electrical Shorting 212 212
Appropriate Term/Code Not Available 204 204
Material Deformation 195 195
Loss of or Failure to Bond 186 186
Device Inoperable 176 176
Therapeutic or Diagnostic Output Failure 173 173
Flare or Flash 171 171
Failure to Power Up 168 168
Failure to Shut Off 164 164
Sticking 163 163
Leak/Splash 140 140
Defective Component 139 139
Fracture 134 134
Component Missing 122 122
Noise, Audible 118 118
Communication or Transmission Problem 117 117
Arcing of Electrodes 116 116
Pitted 114 114
Circuit Failure 114 114
Intermittent Energy Output 114 114
Entrapment of Device 113 113
Device Damaged Prior to Use 107 107
Crack 103 103
Separation Problem 102 102
Image Display Error/Artifact 101 101
Packaging Problem 100 100
Failure to Fire 99 99
Inaccurate Delivery 94 94
Device Stops Intermittently 93 93
No Flow 92 92
Physical Resistance/Sticking 91 91
Blocked Connection 91 91
Improper or Incorrect Procedure or Method 90 90
Suction Problem 90 90
Component Falling 89 89
Loose or Intermittent Connection 88 88
No Device Output 88 88
Fitting Problem 85 85
Activation, Positioning or SeparationProblem 85 85
Loss of Power 83 83
Power Problem 83 83
Environmental Particulates 80 80
Difficult to Remove 79 79
Device Contamination with Chemical or Other Material 75 75
Device Fell 75 75
Intermittent Continuity 73 73
Flaked 72 72
Bent 71 71
Unintended Power Up 64 64
Continuous Firing 62 62
Corroded 61 61
Patient Device Interaction Problem 61 61
Material Split, Cut or Torn 59 59
Intermittent Loss of Power 59 59
Difficult or Delayed Activation 58 58
Device Emits Odor 56 56
Improper Flow or Infusion 53 53
Excessive Heating 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12875 12876
No Clinical Signs, Symptoms or Conditions 5556 5556
No Known Impact Or Consequence To Patient 5419 5419
No Patient Involvement 1897 1897
Burn(s) 1483 1484
No Information 1139 1139
No Code Available 579 579
Blood Loss 564 564
Insufficient Information 556 556
Hemorrhage/Bleeding 509 509
Partial thickness (Second Degree) Burn 359 359
Injury 308 308
Foreign Body In Patient 304 304
Burn, Thermal 302 302
Superficial (First Degree) Burn 243 243
Not Applicable 215 215
Device Embedded In Tissue or Plaque 170 170
Full thickness (Third Degree) Burn 167 167
Pain 161 161
Tissue Damage 151 151
Hematoma 133 133
Patient Problem/Medical Problem 130 130
Bowel Perforation 87 87
Unspecified Infection 85 85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 83 83
Death 82 82
Electric Shock 82 82
Erythema 76 76
Skin Discoloration 76 76
Perforation 58 58
Stenosis 57 57
Unspecified Tissue Injury 56 56
Thrombus 46 46
Inflammation 46 46
Abscess 42 42
Fistula 39 39
Blister 39 39
Seroma 35 35
Thrombosis/Thrombus 34 34
Scar Tissue 33 33
Burning Sensation 32 32
Swelling 31 31
Numbness 31 31
Thrombosis 30 30
Necrosis 30 30
Nerve Damage 30 30
Scarring 29 29
Bruise/Contusion 29 29
Bowel Burn 28 28
Fever 28 28
Shock 27 27
Pneumothorax 27 27
Laceration(s) 25 25
Radiation Exposure, Unintended 25 25
Skin Irritation 24 24
Abdominal Pain 23 23
Laceration(s) of Esophagus 23 23
Post Operative Wound Infection 21 21
Ulcer 19 19
Pleural Effusion 19 19
Phlebitis 18 18
Discomfort 18 18
Skin Tears 17 17
Internal Organ Perforation 17 17
Cardiac Arrest 17 17
Arrhythmia 16 16
Failure to Anastomose 16 16
Dysphagia/ Odynophagia 16 16
Edema 15 15
Chest Pain 15 15
Sepsis 15 15
Reaction 15 15
Cancer 13 13
Peritonitis 13 13
Paralysis 13 13
Wound Dehiscence 13 13
Swelling/ Edema 13 13
Low Blood Pressure/ Hypotension 12 12
Perforation of Esophagus 11 11
Urinary Retention 11 11
Ascites 11 11
Unspecified Gastrointestinal Problem 10 10
Rupture 10 10
Headache 10 10
Pulmonary Embolism 9 9
Atrial Fibrillation 9 9
Bradycardia 9 9
Twitching 9 9
Tachycardia 8 8
Hernia 8 8
Hemostasis 8 8
Rash 8 8
Renal Failure 7 7
Irritation 7 7
Failure of Implant 7 7
Anemia 7 7
Adhesion(s) 7 7
Cyst(s) 7 7
Hypoesthesia 7 7
Intra-Abdominal Hemorrhage 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-09-2019
2 Aesculap Implant Systems LLC II Feb-16-2017
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Nov-15-2019
4 Aomori Olympus Co., Ltd. II Feb-05-2021
5 Applied Medical Resources Corp II Nov-21-2019
6 Beaver-Visitec International Inc. II May-10-2018
7 Beaver-Visitec International Inc. II Apr-27-2018
8 Boston Scientific Corporation II Dec-22-2020
9 Bovie Medical Corporation II Feb-26-2021
10 Bovie Medical Corporation II May-20-2020
11 Bovie Medical Corporation II Oct-19-2018
12 Bovie Medical Corporation II Mar-21-2018
13 COVIDIEN MEDTRONIC II Apr-18-2017
14 ConMed Corporation II Apr-07-2017
15 CooperSurgical, Inc. II Jun-10-2021
16 CooperSurgical, Inc. III Sep-16-2019
17 Covidien II Apr-12-2021
18 Covidien Llc II Jan-13-2022
19 Covidien Llc II Feb-25-2020
20 Covidien, PLC II Mar-18-2019
21 Dannoritzer Medizintechnik GmbH & Co. KG III Oct-03-2018
22 DeRoyal Industries Inc II May-01-2018
23 Ethicon Endo-Surgery Inc II Jun-26-2019
24 Gyrus ACMI, Inc. II Apr-17-2019
25 Integra LifeSciences Corp. II Aug-07-2019
26 Invuity, Inc. II Jul-28-2017
27 Maquet Cardiovascular, LLC II Mar-14-2017
28 Mederi Therapeutics, Inc II May-08-2017
29 Megadyne Medical Products, Inc. II Aug-13-2018
30 Microline Surgical, Inc. II Jun-01-2019
31 Microline Surgical, Inc. II May-08-2018
32 Microline Surgical, Inc. II Feb-02-2018
33 Nico Corp. II Jun-09-2021
34 Olsen Medical II May-25-2018
35 Olympus Corporation of the Americas II Aug-27-2021
36 Solta Medical Inc II Apr-07-2020
37 Stryker Corporation II Mar-17-2020
38 Stryker Instruments Div. of Stryker Corporation II Apr-28-2020
39 Stryker Instruments Div. of Stryker Corporation II Jan-28-2020
40 Sutter Medizintechnik GmbH II Jul-31-2020
41 Teleflex Medical II Jan-18-2019
42 Teleflex Medical II Oct-31-2017
43 Teleflex Medical II Sep-27-2017
44 Terumo Cardiovascular Systems Corporation II Oct-24-2018
45 Xodus Medical Inc II Oct-16-2019
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