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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
2016 15 15
2017 22 22
2018 21 21
2019 20 20
2020 18 18
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 25 25
Device Fell 19 19
Component Falling 5 5
Unsealed Device Packaging 5 5
Material Puncture/Hole 5 5
Split 5 5
Device Packaging Compromised 4 4
Break 3 3
Hole In Material 3 3
Device Dislodged or Dislocated 3 3
Packaging Problem 3 3
Contamination 3 3
Material Integrity Problem 3 3
Loose or Intermittent Connection 3 3
Tear, Rip or Hole in Device Packaging 3 3
Contamination /Decontamination Problem 2 2
Delivered as Unsterile Product 2 2
Mechanical Problem 2 2
Detachment of Device or Device Component 2 2
Component Missing 2 2
Out-Of-Box Failure 2 2
Defective Device 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Device Emits Odor 1 1
Component Incompatible 1 1
Smoking 1 1
Torn Material 1 1
Misassembly by Users 1 1
Output Problem 1 1
Loss of or Failure to Bond 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Unintended Movement 1 1
Image Display Error/Artifact 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 53 53
No Patient Involvement 17 17
No Consequences Or Impact To Patient 9 9
No Clinical Signs, Symptoms or Conditions 9 9
No Information 8 8
Insufficient Information 4 4
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ecolab, Inc. II Feb-05-2018
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