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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
2017 14 14
2018 20 20
2019 18 18
2020 114 114
2021 149 149
2022 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 123 123
Failure to Power Up 43 43
Break 37 37
Defective Device 30 30
No Display/Image 23 23
Display or Visual Feedback Problem 17 17
Erratic or Intermittent Display 12 12
Optical Problem 11 11
Communication or Transmission Problem 7 7
Mechanical Problem 7 7
Poor Quality Image 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Output Problem 6 6
Energy Output Problem 5 5
Display Difficult to Read 5 5
Thermal Decomposition of Device 5 5
Application Program Problem 5 5
Device Operates Differently Than Expected 4 4
Defective Component 4 4
Smoking 4 4
No Device Output 4 4
Fire 4 4
Power Problem 4 4
Image Display Error/Artifact 3 3
Device Operational Issue 3 3
Electrical Power Problem 2 2
Device Displays Incorrect Message 2 2
Sparking 2 2
Overheating of Device 2 2
Loss of Power 2 2
Unintended Power Up 2 2
Temperature Problem 2 2
Noise, Audible 2 2
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Intermittent Communication Failure 1 1
Key or Button Unresponsive/not Working 1 1
Output below Specifications 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Optical Discoloration 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Backflow 1 1
Burst Container or Vessel 1 1
Loose or Intermittent Connection 1 1
Gas Output Problem 1 1
Contamination /Decontamination Problem 1 1
Flare or Flash 1 1
Infusion or Flow Problem 1 1
No Flow 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Microbial Contamination of Device 1 1
Failure to Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 170 170
No Consequences Or Impact To Patient 155 155
No Known Impact Or Consequence To Patient 40 40
Partial thickness (Second Degree) Burn 2 2
No Code Available 2 2
Abdominal Pain 2 2
Air Embolism 1 1
Burn(s) 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Perforation 1 1
Shock 1 1
Injury 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
No Information 1 1

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