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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
3
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
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
34
34
Material Separation
19
19
Fire
12
12
Detachment of Device or Device Component
12
12
Sparking
7
7
Thermal Decomposition of Device
6
6
Failure to Cut
6
6
Material Fragmentation
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Smoking
5
5
Insufficient Information
5
5
Melted
4
4
Overheating of Device
4
4
Temperature Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Fracture
3
3
Electrical /Electronic Property Problem
3
3
Device Handling Problem
2
2
Material Twisted/Bent
2
2
Crack
2
2
Torn Material
2
2
Device Contamination with Chemical or Other Material
2
2
Detachment Of Device Component
2
2
Therapy Delivered to Incorrect Body Area
2
2
Defective Component
2
2
Material Integrity Problem
2
2
Fitting Problem
2
2
Material Frayed
2
2
Dull, Blunt
1
1
Noise, Audible
1
1
Arcing
1
1
Difficult to Open or Close
1
1
Metal Shedding Debris
1
1
Device Dislodged or Dislocated
1
1
Device Disinfection Or Sterilization Issue
1
1
Retraction Problem
1
1
Product Quality Problem
1
1
Device Operates Differently Than Expected
1
1
Unintended Electrical Shock
1
1
Material Disintegration
1
1
Patient-Device Incompatibility
1
1
Unintended Movement
1
1
Contamination /Decontamination Problem
1
1
Patient Device Interaction Problem
1
1
Difficult to Remove
1
1
Mechanical Problem
1
1
Physical Resistance/Sticking
1
1
Entrapment of Device
1
1
Out-Of-Box Failure
1
1
Separation Problem
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
36
36
No Consequences Or Impact To Patient
23
23
Burn(s)
10
10
Insufficient Information
7
7
Partial thickness (Second Degree) Burn
7
7
Hemorrhage/Bleeding
6
6
Foreign Body In Patient
5
5
Device Embedded In Tissue or Plaque
4
4
No Information
3
3
Injury
3
3
No Patient Involvement
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Electric Shock
2
2
Unspecified Reproductive System or Breast Problem
2
2
Abdominal Pain
1
1
Patient Problem/Medical Problem
1
1
No Code Available
1
1
Perforation
1
1
Burn, Thermal
1
1
Pain
1
1
Laceration(s)
1
1
Hormonal Imbalance
1
1
Internal Organ Perforation
1
1
Liver Laceration(s)
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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