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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 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 198 198
Electrical /Electronic Property Problem 185 185
Failure to Power Up 80 80
No Device Output 72 72
Poor Quality Image 55 55
Erratic or Intermittent Display 48 48
Break 44 44
No Visual Prompts/Feedback 40 40
Display or Visual Feedback Problem 37 37
Defective Device 31 31
Output Problem 27 27
Communication or Transmission Problem 22 22
Optical Problem 19 19
Power Problem 19 19
Thermal Decomposition of Device 13 13
Connection Problem 11 11
Overheating of Device 10 10
Activation Failure 10 10
Noise, Audible 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Mechanical Problem 8 8
Flare or Flash 7 7
Loose or Intermittent Connection 6 6
Energy Output Problem 6 6
Defective Component 6 6
Application Program Problem 5 5
Image Display Error/Artifact 5 5
Loss of Power 5 5
Display Difficult to Read 5 5
Signal Artifact/Noise 4 4
Unexpected Shutdown 4 4
Intermittent Loss of Power 4 4
Electrical Power Problem 3 3
Excessive Heating 3 3
Smoking 3 3
Key or Button Unresponsive/not Working 3 3
Off-Label Use 2 2
Temperature Problem 2 2
Corroded 2 2
Defective Alarm 2 2
Sparking 2 2
Blocked Connection 2 2
Material Integrity Problem 2 2
Unintended Power Up 2 2
Operating System Becomes Nonfunctional 1 1
Degraded 1 1
Misconnection 1 1
Optical Obstruction 1 1
Infusion or Flow Problem 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 800 800
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
Blister 1 1
No Information 1 1
Hemorrhage/Bleeding 1 1
Insufficient Information 1 1
Eye Injury 1 1
Shock 1 1
Burn, Thermal 1 1
Injury 1 1
No Patient Involvement 1 1
Death 1 1
Superficial (First Degree) Burn 1 1
Unspecified Tissue Injury 1 1

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