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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
2019 18 18
2020 114 114
2021 149 149
2022 158 158
2023 200 200
2024 296 296
2025 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 220 220
Electrical /Electronic Property Problem 186 186
Failure to Power Up 81 81
No Device Output 75 75
Poor Quality Image 57 57
Erratic or Intermittent Display 55 55
Break 44 44
No Visual Prompts/Feedback 40 40
Display or Visual Feedback Problem 39 39
Defective Device 31 31
Output Problem 28 28
Communication or Transmission Problem 24 24
Power Problem 19 19
Optical Problem 19 19
Thermal Decomposition of Device 13 13
Connection Problem 11 11
Activation Failure 11 11
Noise, Audible 10 10
Overheating of Device 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Mechanical Problem 8 8
Flare or Flash 7 7
Defective Component 7 7
Energy Output Problem 6 6
Loose or Intermittent Connection 6 6
Display Difficult to Read 6 6
Loss of Power 5 5
Unexpected Shutdown 5 5
Application Program Problem 5 5
Image Display Error/Artifact 5 5
Signal Artifact/Noise 4 4
Intermittent Loss of Power 4 4
Smoking 3 3
Electrical Power Problem 3 3
Excessive Heating 3 3
Key or Button Unresponsive/not Working 3 3
Activation Problem 3 3
Temperature Problem 2 2
Sparking 2 2
Corroded 2 2
Off-Label Use 2 2
Defective Alarm 2 2
Unintended Power Up 2 2
Blocked Connection 2 2
Material Integrity Problem 2 2
Backflow 1 1
Infusion or Flow Problem 1 1
Audible Prompt/Feedback Problem 1 1
Misconnection 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 842 842
No Consequences Or Impact To Patient 154 154
No Known Impact Or Consequence To Patient 11 11
Burn(s) 4 4
No Code Available 2 2
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 1 1
Death 1 1
No Information 1 1
Burn, Thermal 1 1
Blister 1 1
Injury 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
Eye Injury 1 1
Shock 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1

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