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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 185 185
No Display/Image 184 184
Failure to Power Up 79 79
No Device Output 67 67
Poor Quality Image 52 52
Erratic or Intermittent Display 46 46
Break 44 44
No Visual Prompts/Feedback 37 37
Display or Visual Feedback Problem 32 32
Defective Device 31 31
Output Problem 27 27
Communication or Transmission Problem 22 22
Power Problem 19 19
Optical Problem 19 19
Thermal Decomposition of Device 13 13
Connection Problem 11 11
Overheating of Device 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Noise, Audible 8 8
Mechanical Problem 8 8
Flare or Flash 7 7
Energy Output Problem 6 6
Defective Component 6 6
Loose or Intermittent Connection 6 6
Loss of Power 5 5
Application Program Problem 5 5
Image Display Error/Artifact 5 5
Display Difficult to Read 5 5
Signal Artifact/Noise 4 4
Intermittent Loss of Power 4 4
Unexpected Shutdown 4 4
Smoking 3 3
Electrical Power Problem 3 3
Key or Button Unresponsive/not Working 3 3
Activation Failure 3 3
Excessive Heating 3 3
Temperature Problem 2 2
Sparking 2 2
Material Integrity Problem 2 2
Blocked Connection 2 2
Unintended Power Up 2 2
Corroded 2 2
Defective Alarm 2 2
Off-Label Use 2 2
Output below Specifications 1 1
Intermittent Communication Failure 1 1
Gas Output Problem 1 1
Circuit Failure 1 1
Disconnection 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 760 760
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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