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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


Premarket Reviews
ManufacturerDecision
KEY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 15 15
2016 15 15
2017 22 22
2018 21 21
2019 20 20
2020 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 24 24
Device Fell 17 17
Cover 16 16
Component Falling 8 8
Split 7 7
Material Puncture/Hole 5 5
Unsealed Device Packaging 5 5
Device Packaging Compromised 5 5
Device Dislodged or Dislocated 4 4
Break 4 4
Material Integrity Problem 4 4
Handpiece 3 3
Contamination 3 3
Loose or Intermittent Connection 3 3
Shield 3 3
Adapter (Adaptor) 3 3
Hole In Material 3 3
Packaging Problem 3 3
Device Operates Differently Than Expected 3 3
Out-Of-Box Failure 2 2
Mechanical Problem 2 2
Detachment Of Device Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 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
Bag 1 1
Failure To Adhere Or Bond 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Emits Odor 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1
Material Separation 1 1
Smoking 1 1
Component Missing 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Particulates 1 1
Torn Material 1 1
Misassembly by Users 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 62 62
No Patient Involvement 17 17
No Consequences Or Impact To Patient 13 13
No Information 9 9
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 1 1
Laceration(s) 1 1

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