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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colonoscope, general & plastic surgery
Regulation Description Endoscope and accessories.
Product CodeFTJ
Regulation Number 876.1500
Device Class 2

Device Problems
Bacterial contamination of device 6
No Information 3
Buckled material 1
Device alarm system issue 1
Device Cleaning Issue 1
No display or display failure 1
Electrical issue 1
Mechanical issue 1
Poor quality image 1
Difficult to position 1
Difficult to remove 1
Inappropriate shock 1
Total Device Problems 19

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