TPLC - Total Product Life Cycle

• 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 Code: GEI
• Regulation Number: 878.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADEOR MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AERIN MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AERIN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
AERIN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP INC.
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC MANAGEMENT PARTNERS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETICS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AGENCY FOR MEDICAL INNOVATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
AGNES MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
ALIC IOTECH, LLC
	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	4
APYX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
	SUBSTANTIALLY EQUIVALENT	2
ARTHROCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AUGUSTINE TEMPERATURE MANAGEMENT LLC
	SUBSTANTIALLY EQUIVALENT	1
AXON SPINE MEDICAL SYSTEM
	SUBSTANTIALLY EQUIVALENT	1
BAISHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BAISHENG MEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING TAKTVOLL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BIPAD SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOLDER SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	4
BOLDER SURGICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
BOMTECH ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON AESTHETICS INC
	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
BRERA MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
BRONCUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
BTL
	SUBSTANTIALLY EQUIVALENT	3
BTL INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	5
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
C2DX, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAMBRIDGE INTERVENTIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CAREFUSION 2200 INC
	SUBSTANTIALLY EQUIVALENT	1
CARTESSA AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
CATHAY MANFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
CHUNGWOO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CLASSYS INC.
	SUBSTANTIALLY EQUIVALENT	1
CNC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COMPAL ELECTRONICS, INC
	SUBSTANTIALLY EQUIVALENT	1
COMPEX, SPOL, S.R.O.
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	6
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	8
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	5
CREO MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
CROSS VASCULAR INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTERA INC.
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	1
CYNOSURE, INC
	SUBSTANTIALLY EQUIVALENT	3
CYNOSURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
DANNIK
	SUBSTANTIALLY EQUIVALENT	2
DANNIK LLC
	SUBSTANTIALLY EQUIVALENT	2
DELTRONIX EQUIPAMENTOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
DEX SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
E SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLUSA, LLC
	SUBSTANTIALLY EQUIVALENT	4
ENCISION INC.
	SUBSTANTIALLY EQUIVALENT	1
ENCISION INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
ENERGIST LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	6
ETHICON ENDO-SURGERY
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO-SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	8
ETHICON ENDO-SURGERY, LLC (A JOHNSON AND JOHNSON COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
EUNSUNG GLOBAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXCELSIOR RESOURCES LLC
	SUBSTANTIALLY EQUIVALENT	1
F CARE SYSTEMS USA LLC
	SUBSTANTIALLY EQUIVALENT	1
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
GMV S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
GOWOONSESANG COSMETICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU AIMIRA INNOVATION TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUENTER BISSINGER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GUNTER BISSINGER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
HG INNOVATIONS LTD
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HOOGLAND SPINE PRODUCTS, GMBH
	SUBSTANTIALLY EQUIVALENT	1
HS HOSPITAL SERVICE SPA
	SUBSTANTIALLY EQUIVALENT	2
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INBELLA MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
INDIBA S.A.U
	SUBSTANTIALLY EQUIVALENT	1
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	7
INMODE MD LTD.
	SUBSTANTIALLY EQUIVALENT	5
INNOBLATIVE DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA MICROFRANCE
	SUBSTANTIALLY EQUIVALENT	1
INTELIS INSTRUMENTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTUITIVE SURGICAL
	SUBSTANTIALLY EQUIVALENT	4
INVUITY INC.
	SUBSTANTIALLY EQUIVALENT	1
ITALIAN ENGINEERING SRL
	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	4
JEISYS MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HOPE BIOMEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HOPE BIOMEDICAL SCIENCE&TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU RONG FU KANG MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KATALYST SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
KIRWAN SURGICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
KLS MARTIN GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LED SPA
	SUBSTANTIALLY EQUIVALENT	1
LEXINGTON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	2
LIVSMED INC.
	SUBSTANTIALLY EQUIVALENT	10
LUMENDI, LLC
	SUBSTANTIALLY EQUIVALENT	2
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOVASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	2
MAQUET CARDIOVASCULAR, LLC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDRANGE
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC ADVANCED ENERGY
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MICROLINE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
	SUBSTANTIALLY EQUIVALENT	4
NEAUVIA NORTH AMERICA, INC
	SUBSTANTIALLY EQUIVALENT	3
NEURENT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
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
NINGBO SHUN YE MEDICAL COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NISSHA MEDICAL TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
NOVOXEL LTD.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	7
PAVMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN LTD
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN LTD.
	SUBSTANTIALLY EQUIVALENT	5
PRECISION SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
PULSE BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	7
REBOUND THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	4
RELIGN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
RF MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SAFER SURGERIES MEDICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEJONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENB CO LTD
	SUBSTANTIALLY EQUIVALENT	5
SHENB CO LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENB CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHINING WORLD HEALTH CARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SINGLE PASS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SKINGRAB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLTA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SONIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	5
SPIRATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
STARMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	3
SURGICAL DIRECT, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL PRINCIPALS, 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	5
SYNERON MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TENTECH 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	2
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	2
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	3
VHMED (NANTONG) CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIOL CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
VIOL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
VIVEVE INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVEVE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VIVEVE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
VIVEVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WON TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2017	6069	6069
2018	6545	6545
2019	7066	7066
2020	6490	6490
2021	6351	6351
2022	6103	6103
2023	7177	7177
2024	7899	7900
2025	1171	1171

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	8312	8312
Adverse Event Without Identified Device or Use Problem	5438	5438
Energy Output Problem	3418	3418
Detachment of Device or Device Component	2954	2954
Difficult to Open or Close	2658	2658
Electrical /Electronic Property Problem	2069	2069
Peeled/Delaminated	2042	2042
Output Problem	1391	1391
Self-Activation or Keying	1248	1248
Insufficient Information	1139	1139
Device Displays Incorrect Message	1079	1079
Material Separation	1009	1009
Failure to Deliver Energy	941	941
Material Twisted/Bent	897	898
Mechanical Problem	894	894
Retraction Problem	891	891
Sparking	889	889
Fire	866	866
Delivered as Unsterile Product	801	801
Melted	792	792
Failure to Cut	753	753
Material Fragmentation	721	721
Overheating of Device	702	702
Detachment Of Device Component	697	697
Energy Output To Patient Tissue Incorrect	665	665
Activation Problem	634	634
Device Alarm System	625	625
Protective Measures Problem	605	605
Connection Problem	577	577
Appropriate Term/Code Not Available	568	568
Use of Device Problem	557	557
Device Remains Activated	530	530
Infusion or Flow Problem	529	529
Application Program Problem: Parameter Calculation Error	517	517
Arcing	496	496
Smoking	494	494
Device Operates Differently Than Expected	484	484
Communication or Transmission Problem	474	474
Mechanical Jam	466	466
Material Integrity Problem	433	433
No Apparent Adverse Event	430	430
Fracture	425	425
Intermittent Energy Output	424	424
Electrical Shorting	422	422
Defective Device	405	405
Temperature Problem	395	395
Material Deformation	328	328
Suction Failure	290	290
Thermal Decomposition of Device	289	289
Unintended Power Up	262	262

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22461	22462
No Consequences Or Impact To Patient	12879	12880
No Known Impact Or Consequence To Patient	5419	5419
Burn(s)	2599	2600
Insufficient Information	2137	2137
No Patient Involvement	1897	1897
Hemorrhage/Bleeding	1679	1679
No Information	1141	1141
Partial thickness (Second Degree) Burn	688	688
Superficial (First Degree) Burn	623	623
Foreign Body In Patient	601	601
No Code Available	580	580
Blood Loss	565	565
Full thickness (Third Degree) Burn	354	354
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	345	345
Pain	317	317
Injury	309	309
Burn, Thermal	302	302
Unspecified Tissue Injury	260	260
Hematoma	226	226
Not Applicable	215	215
Erythema	212	212
Device Embedded In Tissue or Plaque	186	186
Blister	174	174
Unspecified Infection	160	160
Tissue Damage	151	151
Electric Shock	143	143
Scar Tissue	136	136
Patient Problem/Medical Problem	130	130
Bowel Perforation	128	128
Skin Discoloration	119	119
Perforation	108	108
Laceration(s)	88	88
Necrosis	84	84
Death	82	82
Thrombosis/Thrombus	77	77
Stenosis	75	75
Inflammation	74	74
Fistula	71	71
Abscess	68	68
Swelling/ Edema	67	67
Bowel Burn	64	64
Fever	63	63
Nerve Damage	62	62
Skin Inflammation/ Irritation	56	56
Pneumothorax	55	55
Post Operative Wound Infection	52	52
Unintended Radiation Exposure	51	51
Abdominal Pain	49	49
Internal Organ Perforation	49	49

Recalls
Manufacturer		Recall Class	Date Posted
1	Aerin Medical, Inc.	II	Jan-06-2025
2	Aesculap Implant Systems LLC	II	May-05-2023
3	Aesculap Implant Systems LLC	II	Sep-09-2019
4	Aesculap Implant Systems LLC	II	Feb-16-2017
5	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Nov-15-2019
6	Aomori Olympus Co., Ltd.	II	Feb-05-2021
7	Applied Medical Resources Corp	II	Nov-21-2019
8	Bard Peripheral Vascular Inc	II	Nov-13-2024
9	Beaver Visitec International, Inc.	II	Jun-23-2022
10	Beaver-Visitec International Inc.	II	May-10-2018
11	Beaver-Visitec International Inc.	II	Apr-27-2018
12	Bolder Surgical, LLC	II	Mar-08-2022
13	Boston Scientific Corporation	II	Dec-22-2020
14	Bovie Medical Corporation	II	Feb-26-2021
15	Bovie Medical Corporation	II	May-20-2020
16	Bovie Medical Corporation	II	Oct-19-2018
17	Bovie Medical Corporation	II	Mar-21-2018
18	COVIDIEN MEDTRONIC	II	Apr-18-2017
19	Carefusion 2200 Inc	II	Dec-03-2022
20	ConMed Corporation	II	Dec-09-2022
21	ConMed Corporation	II	Apr-07-2017
22	CooperSurgical, Inc.	II	Jun-10-2021
23	CooperSurgical, Inc.	III	Sep-16-2019
24	Covidien	II	Jan-03-2024
25	Covidien	II	Apr-12-2021
26	Covidien Llc	II	Jan-13-2022
27	Covidien Llc	II	Feb-25-2020
28	Covidien, PLC	II	Mar-18-2019
29	Dannoritzer Medizintechnik GmbH & Co. KG	III	Oct-03-2018
30	DeRoyal Industries Inc	II	May-01-2018
31	Ethicon Endo-Surgery Inc	II	Jun-26-2019
32	Gyrus ACMI, Inc.	II	Apr-17-2019
33	Integra LifeSciences Corp.	II	Aug-07-2019
34	Intuitive Surgical, Inc.	II	May-31-2022
35	Invuity, Inc.	II	Jul-28-2017
36	Kirwan Surgical Products, LLC	I	Dec-16-2024
37	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
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