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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
Product CodeFTA
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 20 20
2020 18 18
2021 20 20
2022 14 14
2023 105 105
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 110 110
Crack 27 27
Device Fell 22 22
Unsealed Device Packaging 7 7
Material Puncture/Hole 6 6
Contamination 5 5
Display or Visual Feedback Problem 3 3
Contamination /Decontamination Problem 3 3
Component Missing 3 3
No Apparent Adverse Event 2 2
Flaked 2 2
Product Quality Problem 2 2
Peeled/Delaminated 2 2
Delivered as Unsterile Product 2 2
Device Emits Odor 1 1
Smoking 1 1
Use of Device Problem 1 1
Defective Component 1 1
Image Display Error/Artifact 1 1
Electrical /Electronic Property Problem 1 1
Corroded 1 1
No Display/Image 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Contamination of Device Ingredient or Reagent 1 1
Intermittent Loss of Power 1 1
Device Contaminated at the User Facility 1 1
Break 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Defective Device 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
No Known Impact Or Consequence To Patient 25 25
Insufficient Information 19 19
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
Unspecified Infection 1 1

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