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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 298 298

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 351 351
No Display/Image 107 107
Break 71 71
Communication or Transmission Problem 71 71
Display or Visual Feedback Problem 29 29
Erratic or Intermittent Display 25 25
Scratched Material 25 25
Material Split, Cut or Torn 19 19
Optical Problem 19 19
Dent in Material 19 19
Output Problem 16 16
Loose or Intermittent Connection 15 15
Image Display Error/Artifact 15 15
Material Integrity Problem 14 14
Leak/Splash 13 13
Crack 13 13
Image Orientation Incorrect 13 13
Failure to Clean Adequately 13 13
Material Discolored 12 12
Contamination 9 9
Fracture 7 7
Defective Component 7 7
Connection Problem 5 5
Mechanical Problem 4 4
Defective Device 4 4
Material Deformation 4 4
Electrical /Electronic Property Problem 3 3
Optical Discoloration 3 3
Sharp Edges 3 3
Gas/Air Leak 3 3
Material Opacification 3 3
Degraded 2 2
Optical Distortion 2 2
Contamination /Decontamination Problem 2 2
Moisture or Humidity Problem 2 2
Detachment of Device or Device Component 2 2
Unintended Movement 2 2
Optical Obstruction 2 2
Corroded 2 2
Circuit Failure 2 2
Fogging 1 1
Material Fragmentation 1 1
Key or Button Unresponsive/not Working 1 1
Moisture Damage 1 1
Lack of Effect 1 1
Electrical Overstress 1 1
Smoking 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination with Chemical or Other Material 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 755 755
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 5 5
Foreign Body In Patient 1 1

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