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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, television, endoscopic, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWF
Regulation Number 878.4160
Device Class 1

Device Problems
Intermittent Continuity 12
Intermittent loss of power 6
Failure to Power Up 4
Poor Quality Image 2
Intermittent Capture 2
Intermittent Energy Output 2
Electrical /Electronic Property Problem 1
Optical Distortion 1
Device Stops Intermittently 1
Device Operates Differently Than Expected 1
Operating System Becomes Nonfunctional 1
Computer Software Problem 1
Loose or Intermittent Connection 1
Sensing Intermittently 1
Device Contamination with Chemical or Other Material 1
Image Display Error / Artifact 1
Computer Operating System Problem 1
Unexpected Shutdown 1
Total Device Problems 40


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