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TPLC
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show TPLC since
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Device
coagulator-cutter, endoscopic, unipolar (and accessories)
Product Code
KNF
Regulation Number
884.4160
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
GYNESONICS, INC
SUBSTANTIALLY EQUIVALENT
2
GYNESONICS, INC.
SUBSTANTIALLY EQUIVALENT
3
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
LINA MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
MEDSYS, S.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
7
7
2016
9
9
2017
22
22
2018
13
13
2019
18
18
2020
19
19
2021
9
9
2022
16
16
2023
33
33
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
34
34
Material Separation
19
19
Detachment of Device or Device Component
12
12
Fire
12
12
Sparking
7
7
Thermal Decomposition of Device
6
6
Material Fragmentation
6
6
Failure to Cut
6
6
Smoking
5
5
Overheating of Device
4
4
Improper or Incorrect Procedure or Method
4
4
Melted
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Temperature Problem
4
4
Insufficient Information
4
4
Fracture
3
3
Electrical /Electronic Property Problem
3
3
Detachment Of Device Component
2
2
Crack
2
2
Material Frayed
2
2
Therapy Delivered to Incorrect Body Area
2
2
Fitting Problem
2
2
Defective Component
2
2
Device Contamination with Chemical or Other Material
2
2
Device Handling Problem
2
2
Torn Material
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Unintended Movement
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Physical Resistance/Sticking
1
1
Unintended Electrical Shock
1
1
Separation Problem
1
1
Material Deformation
1
1
Patient-Device Incompatibility
1
1
Contamination /Decontamination Problem
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Out-Of-Box Failure
1
1
Dull, Blunt
1
1
Arcing
1
1
Product Quality Problem
1
1
Metal Shedding Debris
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Material Rupture
1
1
Mechanical Problem
1
1
Misassembled
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
45
45
No Clinical Signs, Symptoms or Conditions
35
35
No Consequences Or Impact To Patient
23
23
Burn(s)
10
10
Insufficient Information
7
7
Partial thickness (Second Degree) Burn
6
6
Hemorrhage/Bleeding
6
6
Foreign Body In Patient
5
5
Device Embedded In Tissue or Plaque
4
4
Injury
3
3
No Information
3
3
No Patient Involvement
3
3
Electric Shock
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Reproductive System or Breast Problem
1
1
Patient Problem/Medical Problem
1
1
Pain
1
1
Burn, Thermal
1
1
Perforation
1
1
Laceration(s)
1
1
Liver Laceration(s)
1
1
No Code Available
1
1
Internal Organ Perforation
1
1
Hormonal Imbalance
1
1
Abdominal Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Feb-26-2013
2
Integra Limited
II
Jul-18-2012
3
LINA Medical ApS
II
Jun-28-2011
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