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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light source, endoscope, xenon arc
Regulation Description Endoscope and accessories.
Product CodeGCT
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 114 114
2021 149 149
2022 158 158
2023 200 200
2024 296 296
2025 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 221 221
Electrical /Electronic Property Problem 186 186
Failure to Power Up 83 83
No Device Output 78 78
Poor Quality Image 59 59
Erratic or Intermittent Display 57 57
Break 45 45
No Visual Prompts/Feedback 40 40
Display or Visual Feedback Problem 38 38
Defective Device 29 29
Output Problem 28 28
Communication or Transmission Problem 24 24
Power Problem 19 19
Optical Problem 16 16
Activation Failure 13 13
Thermal Decomposition of Device 13 13
Connection Problem 11 11
Noise, Audible 10 10
Overheating of Device 9 9
Mechanical Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Defective Component 7 7
Flare or Flash 7 7
Energy Output Problem 6 6
Loose or Intermittent Connection 6 6
Display Difficult to Read 5 5
Image Display Error/Artifact 5 5
Application Program Problem 5 5
Intermittent Loss of Power 5 5
Loss of Power 5 5
Unexpected Shutdown 5 5
Activation Problem 5 5
Signal Artifact/Noise 4 4
Electrical Power Problem 3 3
Device Alarm System 3 3
Excessive Heating 3 3
Key or Button Unresponsive/not Working 3 3
Detachment of Device or Device Component 3 3
Output below Specifications 2 2
Corroded 2 2
Defective Alarm 2 2
Off-Label Use 2 2
Material Deformation 2 2
Blocked Connection 2 2
Material Integrity Problem 2 2
Smoking 2 2
Unintended Power Up 2 2
Audible Prompt/Feedback Problem 1 1
Misconnection 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 864 864
No Consequences Or Impact To Patient 142 142
No Known Impact Or Consequence To Patient 10 10
Burn(s) 4 4
Death 1 1
No Code Available 1 1
No Information 1 1
Blister 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
Eye Injury 1 1
Unspecified Tissue Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Hemorrhage/Bleeding 1 1

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