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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device box, battery, rechargeable
Regulation Description Endoscope and accessories.
Product CodeFCO
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2016 18 18
2017 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 12 12
Smoking 3 3
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Noise, Audible 1 1
Electrical /Electronic Property Problem 1 1
Material Rupture 1 1
Fire 1 1
Device Emits Odor 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 9 9
No Information 8 8
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 2 2
Respiratory Distress 1 1

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