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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

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 503 503
No Display/Image 143 143
Break 121 121
Communication or Transmission Problem 88 88
Dent in Material 41 41
Erratic or Intermittent Display 35 35
Scratched Material 34 34
Optical Problem 33 33
Display or Visual Feedback Problem 33 33
Material Split, Cut or Torn 31 31
Output Problem 25 25
Fracture 18 18
Sharp Edges 18 18
Failure to Clean Adequately 18 18
Material Integrity Problem 18 18
Loose or Intermittent Connection 18 18
Crack 18 18
Image Orientation Incorrect 17 17
Image Display Error/Artifact 16 16
Leak/Splash 15 15
Material Discolored 12 12
Contamination 9 9
Connection Problem 9 9
Degraded 9 9
Material Deformation 9 9
Defective Component 7 7
Corroded 6 6
Unintended Movement 5 5
Mechanical Problem 5 5
Electrical /Electronic Property Problem 4 4
Defective Device 4 4
Optical Discoloration 4 4
Gas/Air Leak 4 4
Moisture or Humidity Problem 4 4
Material Opacification 3 3
Optical Distortion 3 3
Detachment of Device or Device Component 3 3
Optical Obstruction 2 2
Self-Activation or Keying 2 2
Contamination /Decontamination Problem 2 2
Material Twisted/Bent 2 2
Disconnection 2 2
Circuit Failure 2 2
Mechanical Jam 1 1
Flushing Problem 1 1
Fluid/Blood Leak 1 1
Misfocusing 1 1
No Device Output 1 1
Activation Failure 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1071 1071
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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