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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resectoscope
Regulation Description Endoscope and accessories.
Product CodeFJL
Regulation Number 876.1500
Device Class 2

Device Problems
Break 125
Material Fragmentation 70
Fracture 65
Mechanical Problem 65
Tip 36
Insulation 3
Detachment Of Device Component 2
Mechanical Jam 1
Device Operates Differently Than Expected 1
Bent 1
Component Falling 1
Device Handling Problem 1
Adverse Event Without Identified Device or Use Problem 1
Trocar 1
Total Device Problems 373


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