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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
2014 1 1
2016 3 3
2019 2 2
2022 3 3
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Detachment of Device or Device Component 3 3
Device Issue 2 2
Labelling, Instructions for Use or Training Problem 2 2
Overheating of Device 1 1
Detachment Of Device Component 1 1
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 4 4
No Information 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jul-23-2016
2 Pentax Medical Company II Jun-28-2016
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