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TPLC
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show TPLC since
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Device
endoscope, rigid
Regulation Description
Endoscope and accessories.
Product Code
GCM
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
1
1
2021
5
5
2022
4
4
2023
2
2
2024
449
449
2025
62
62
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
237
237
No Display/Image
77
77
Communication or Transmission Problem
46
46
Break
43
43
Display or Visual Feedback Problem
22
22
Scratched Material
21
21
Erratic or Intermittent Display
18
18
Material Split, Cut or Torn
14
14
Optical Problem
13
13
Material Discolored
12
12
Crack
11
11
Material Integrity Problem
10
10
Loose or Intermittent Connection
10
10
Dent in Material
10
10
Failure to Clean Adequately
9
9
Contamination
9
9
Output Problem
8
8
Image Display Error/Artifact
8
8
Image Orientation Incorrect
7
7
Fracture
6
6
Leak/Splash
6
6
Defective Component
5
5
Connection Problem
4
4
Material Opacification
3
3
Mechanical Problem
3
3
Material Deformation
3
3
Defective Device
3
3
Optical Discoloration
2
2
Optical Distortion
2
2
Unintended Movement
2
2
Detachment of Device or Device Component
2
2
Sharp Edges
2
2
Degraded
2
2
Material Fragmentation
1
1
Self-Activation or Keying
1
1
Compatibility Problem
1
1
Misfocusing
1
1
Mechanical Jam
1
1
Moisture Damage
1
1
Corroded
1
1
Flushing Problem
1
1
Gas/Air Leak
1
1
Optical Obstruction
1
1
Incomplete or Inadequate Connection
1
1
Material Puncture/Hole
1
1
Display Difficult to Read
1
1
Disconnection
1
1
Smoking
1
1
Moisture or Humidity Problem
1
1
Electrical Overstress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
518
518
No Known Impact Or Consequence To Patient
6
6
Insufficient Information
4
4
Foreign Body In Patient
1
1
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