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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
2020 18 18
2021 20 20
2022 14 14
2023 105 105
2024 29 29
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 116 116
Crack 20 20
Device Fell 15 15
Unsealed Device Packaging 10 10
Display or Visual Feedback Problem 9 9
Contamination 7 7
Contamination /Decontamination Problem 4 4
Component Missing 3 3
Device Contamination with Chemical or Other Material 3 3
Break 2 2
No Display/Image 2 2
Peeled/Delaminated 2 2
Material Puncture/Hole 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
No Apparent Adverse Event 2 2
Flaked 2 2
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Output Problem 1 1
Image Display Error/Artifact 1 1
Insufficient Information 1 1
Smoking 1 1
Defective Component 1 1
Defective Device 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Mechanics Altered 1 1
Device Emits Odor 1 1
Tear, Rip or Hole in Device Packaging 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 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 171 171
Insufficient Information 20 20
No Known Impact Or Consequence To Patient 9 9
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1

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