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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sphyncteroscope
Product CodeFDR
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2014 8 8
2015 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Failure to Align 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Perforation 1 1

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