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TPLC
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Device
coagulator-cutter, endoscopic, unipolar (and accessories)
Regulation Description
Unipolar endoscopic coagulator-cutter and accessories.
Product Code
KNF
Regulation Number
884.4160
Device Class
2
Premarket Reviews
Manufacturer
Decision
GYNESONICS, INC
SUBSTANTIALLY EQUIVALENT
3
GYNESONICS, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
19
19
2021
9
9
2022
16
16
2023
33
33
2024
13
13
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
23
23
Detachment of Device or Device Component
11
11
Material Separation
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Insufficient Information
4
4
Melted
4
4
Improper or Incorrect Procedure or Method
3
3
Failure to Cut
3
3
Material Fragmentation
3
3
Smoking
3
3
Sparking
3
3
Fracture
3
3
Mechanical Problem
2
2
Excessive Heating
2
2
Overheating of Device
2
2
Fire
2
2
Material Integrity Problem
2
2
Fitting Problem
2
2
Material Frayed
1
1
Material Twisted/Bent
1
1
Crack
1
1
Defective Component
1
1
Dull, Blunt
1
1
Patient Device Interaction Problem
1
1
Material Rupture
1
1
Physical Resistance/Sticking
1
1
Difficult to Remove
1
1
Material Deformation
1
1
Patient-Device Incompatibility
1
1
Device Contamination with Chemical or Other Material
1
1
Therapy Delivered to Incorrect Body Area
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
40
40
No Consequences Or Impact To Patient
8
8
Burn(s)
7
7
Insufficient Information
7
7
Partial thickness (Second Degree) Burn
6
6
Foreign Body In Patient
4
4
Hemorrhage/Bleeding
4
4
No Known Impact Or Consequence To Patient
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Sepsis
2
2
Unspecified Reproductive System or Breast Problem
2
2
Bowel Burn
2
2
Unspecified Tissue Injury
1
1
No Patient Involvement
1
1
Bowel Perforation
1
1
Device Embedded In Tissue or Plaque
1
1
Patient Problem/Medical Problem
1
1
Laceration(s)
1
1
Electric Shock
1
1
Hormonal Imbalance
1
1
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