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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, rigid
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
2017 3 3
2018 1 1
2019 5 5
2020 1 1
2021 5 5
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 6 6
Poor Quality Image 2 2
Microbial Contamination of Device 2 2
Material Deformation 2 2
Optical Distortion 1 1
Unintended Movement 1 1
Device Handling Problem 1 1
Material Opacification 1 1
Smoking 1 1
Break 1 1
Display or Visual Feedback Problem 1 1
Moisture Damage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
No Patient Involvement 2 2

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