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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sphyncteroscope
Regulation Description Endoscope and accessories.
Product CodeFDR
Regulation Number 876.1500
Device Class 2

Device Problems
Break 34
Device operates differently than expected 3
Dislodged or dislocated 3
Failure to align 2
No Known Device Problem 1
Balloon rupture 1
Total Device Problems 44

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