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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, fiberoptic
Regulation Description Surgical lamp.
Product CodeFST
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 13 13
2016 15 15
2017 20 20
2018 12 12
2019 29 29
2020 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 18 18
Break 17 17
Temperature Problem 16 16
Detachment of Device or Device Component 14 14
Thermal Decomposition of Device 10 10
Melted 9 9
Fracture 7 7
Device Emits Odor 6 6
Device Operates Differently Than Expected 5 5
Cannula 5 5
Trocar 5 5
Material Separation 4 4
Cable, Electrical 4 4
Use of Device Problem 3 3
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Cover 3 3
Component Falling 3 3
Material Discolored 2 2
Fiber 2 2
Improper or Incorrect Procedure or Method 2 2
Dull, Blunt 2 2
Device Subassembly 2 2
Excessive Heating 2 2
Smoking 2 2
Material Fragmentation 2 2
Crack 2 2
Fire 2 2
Device Dislodged or Dislocated 2 2
Inadequate Lighting 2 2
Sparking 2 2
Device Packaging Compromised 1 1
Tip 1 1
Knife 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Separation Problem 1 1
Fogging 1 1
Power Supply 1 1
Ring 1 1
Charred 1 1
Component Incompatible 1 1
Component Missing 1 1
Defective Device 1 1
Unsealed Device Packaging 1 1
Fiberoptic 1 1
Yoke 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Difficult or Delayed Activation 1 1
Contamination /Decontamination Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Power Problem 1 1
Connector Pin 1 1
Device Damaged Prior to Use 1 1
Circuit Failure 1 1
Detachment Of Device Component 1 1
Lamp 1 1
Hub 1 1
Valve(s) 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Inability to Irrigate 1 1
Leak/Splash 1 1
Unintended Collision 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 41 41
No Known Impact Or Consequence To Patient 41 41
No Patient Involvement 8 8
Burn(s) 7 7
Burn, Thermal 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Partial thickness (Second Degree) Burn 3 3
No Code Available 3 3
Injury 3 3
Discomfort 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Skin Discoloration 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Jan-07-2015
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