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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, surgical, accessories
Regulation Description Surgical lamp.
Product CodeFTA
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2021 20 20
2022 14 14
2023 105 105
2024 29 29
2025 19 19
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 111 111
Display or Visual Feedback Problem 26 26
Crack 12 12
Unsealed Device Packaging 11 11
No Display/Image 2 2
No Apparent Adverse Event 2 2
Computer Software Problem 2 2
Electrical /Electronic Property Problem 2 2
Flaked 2 2
Separation Problem 1 1
Break 1 1
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Contamination 1 1
Use of Device Problem 1 1
Insufficient Device Problem Information 1 1
Audible Prompt/Feedback Problem 1 1
Device Handling Problem 1 1
Intermittent Loss of Power 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Insufficient Information 17 17
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Apr-28-2023
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