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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
2020 4 4
2021 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Failure to Align 1 1
Unintended Movement 1 1
Malposition of Device 1 1
Poor Quality Image 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

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

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