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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, rigid
Regulation Description Endoscope and accessories.
Product CodeGCM
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
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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