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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 114 114
Crack 20 20
Device Fell 15 15
Display or Visual Feedback Problem 7 7
Unsealed Device Packaging 7 7
Contamination 5 5
Contamination /Decontamination Problem 3 3
Component Missing 3 3
Peeled/Delaminated 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Material Puncture/Hole 2 2
Flaked 2 2
No Apparent Adverse Event 2 2
Break 2 2
No Display/Image 2 2
Intermittent Loss of Power 1 1
Mechanics Altered 1 1
Corroded 1 1
Structural Problem 1 1
Device Emits Odor 1 1
Electrical /Electronic Property Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Split, Cut or Torn 1 1
Mechanical Jam 1 1
Defective Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Insufficient Information 1 1
Tear, Rip or Hole in Device Packaging 1 1
Separation Problem 1 1
Device Contaminated at the User Facility 1 1
Use of Device Problem 1 1
Defective Component 1 1
Smoking 1 1
Image Display Error/Artifact 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
Insufficient Information 19 19
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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