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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, microsurgical
Regulation Description Surgical camera and accessories.
Product CodeFTH
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2016 13 13
2017 13 13
2019 2 2
2020 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 5 5
Device Operates Differently Than Expected 5 5
Positioning Problem 5 5
Unintended Movement 3 3
Failure to Align 3 3
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Device Remains Activated 1 1
Self-Activation or Keying 1 1
Use of Device Problem 1 1
Application Program Problem 1 1
Mechanical Problem 1 1
No Visual Prompts/Feedback 1 1
Temperature Problem 1 1
Flare or Flash 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Overcorrection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Code Available 8 8
Visual Impairment 3 3
Discomfort 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
No Consequences Or Impact To Patient 1 1
Burn(s) 1 1
Chemosis 1 1
Corneal Touch 1 1
Erythema 1 1
Failure of Implant 1 1

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