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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 camera, still, surgical
Regulation Description Surgical camera and accessories.
Product CodeFTT
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 13 13
2018 1 1
2019 2 2
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure To Adhere Or Bond 7 7
Entrapment of Device 2 2
Device Damaged Prior to Use 2 2
Premature Activation 2 2
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Display or Visual Feedback Problem 1 1
Loss of Power 1 1
Failure to Power Up 1 1
High pH 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 7 7
Radiation Exposure, Unintended 2 2
Not Applicable 1 1
No Code Available 1 1
Abdominal Pain 1 1
Injury 1 1
Obstruction/Occlusion 1 1

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