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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
2020 1 1
2021 5 5
2022 4 4
2023 2 2
2024 449 449
2025 442 442

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 434 434
No Display/Image 118 118
Communication or Transmission Problem 80 80
Break 78 78
Display or Visual Feedback Problem 32 32
Erratic or Intermittent Display 30 30
Scratched Material 26 26
Optical Problem 25 25
Dent in Material 23 23
Material Split, Cut or Torn 21 21
Output Problem 20 20
Loose or Intermittent Connection 18 18
Crack 17 17
Image Display Error/Artifact 16 16
Image Orientation Incorrect 16 16
Leak/Splash 15 15
Material Integrity Problem 15 15
Material Discolored 12 12
Failure to Clean Adequately 9 9
Contamination 9 9
Connection Problem 8 8
Fracture 7 7
Defective Component 7 7
Material Deformation 5 5
Mechanical Problem 5 5
Electrical /Electronic Property Problem 4 4
Unintended Movement 4 4
Defective Device 4 4
Moisture or Humidity Problem 4 4
Optical Discoloration 4 4
Gas/Air Leak 4 4
Detachment of Device or Device Component 3 3
Material Opacification 3 3
Corroded 3 3
Sharp Edges 3 3
Degraded 3 3
Material Twisted/Bent 2 2
Optical Distortion 2 2
Contamination /Decontamination Problem 2 2
Self-Activation or Keying 2 2
Optical Obstruction 2 2
Circuit Failure 2 2
Flushing Problem 1 1
Mechanical Jam 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
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 898 898
Insufficient Information 5 5
Air Embolism 1 1
Brain Injury 1 1
Cardiac Arrest 1 1
Electrolyte Imbalance 1 1
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Hyperventilation 1 1

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