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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sigmoidoscope and accessories, flexible/rigid
Definition to examine and perform procedures within the sigmoid (descending) colon
Product CodeFAM
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2022 3 3
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 3 3
Break 2 2
Labelling, Instructions for Use or Training Problem 2 2
Erratic or Intermittent Display 1 1
Optical Distortion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 2 2

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