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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
2021 5 5
2022 4 4
2023 2 2
2024 449 449
2025 616 616
2026 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 551 551
No Display/Image 152 152
Break 128 128
Communication or Transmission Problem 96 96
Dent in Material 46 46
Erratic or Intermittent Display 36 36
Scratched Material 36 36
Display or Visual Feedback Problem 34 34
Optical Problem 33 33
Material Split, Cut or Torn 32 32
Output Problem 27 27
Failure to Clean Adequately 24 24
Sharp Edges 20 20
Loose or Intermittent Connection 19 19
Fracture 19 19
Crack 18 18
Material Integrity Problem 18 18
Image Display Error/Artifact 17 17
Image Orientation Incorrect 17 17
Leak/Splash 16 16
Material Discolored 12 12
Connection Problem 12 12
Degraded 11 11
Material Deformation 9 9
Contamination 9 9
Defective Component 8 8
Electrical /Electronic Property Problem 6 6
Corroded 6 6
Mechanical Problem 5 5
Optical Discoloration 5 5
Unintended Movement 5 5
Moisture or Humidity Problem 4 4
Gas/Air Leak 4 4
Defective Device 4 4
Optical Distortion 3 3
Detachment of Device or Device Component 3 3
Material Opacification 3 3
No Device Output 3 3
Self-Activation or Keying 2 2
Optical Obstruction 2 2
Misfocusing 2 2
Material Twisted/Bent 2 2
Contamination /Decontamination Problem 2 2
Disconnection 2 2
Circuit Failure 2 2
Material Fragmentation 1 1
Lack of Effect 1 1
Fogging 1 1
Key or Button Unresponsive/not Working 1 1
Residue After Decontamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1161 1161
Insufficient Information 6 6
Air Embolism 1 1
Brain Injury 1 1
Cardiac Arrest 1 1
Electrolyte Imbalance 1 1
Foreign Body In Patient 1 1
Hyperventilation 1 1

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