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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, still, microsurgical
Product CodeFTH
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 4 4
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
No Visual Prompts/Feedback 1 1
Poor Quality Image 1 1
Self-Activation or Keying 1 1
Failure to Align 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Visual Impairment 2 2
Failure of Implant 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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