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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
Product CodeFST
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 33 33
2021 20 20
2022 11 11
2023 11 11
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 46 46
Detachment of Device or Device Component 18 18
Break 11 11
Melted 10 10
Material Integrity Problem 8 8
Excessive Heating 8 8
Temperature Problem 6 6
Fracture 6 6
Smoking 6 6
Material Separation 5 5
Thermal Decomposition of Device 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Emits Odor 3 3
Physical Resistance/Sticking 3 3
Dull, Blunt 2 2
Disconnection 2 2
Device Fell 2 2
Material Discolored 2 2
Material Fragmentation 2 2
Difficult to Remove 2 2
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Insert 1 1
Material Deformation 1 1
Optical Problem 1 1
Malposition of Device 1 1
Fire 1 1
Material Protrusion/Extrusion 1 1
Component Missing 1 1
Use of Device Problem 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Crack 1 1
Material Frayed 1 1
Device Slipped 1 1
Separation Problem 1 1
Leak/Splash 1 1
Sparking 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
No Consequences Or Impact To Patient 31 31
No Known Impact Or Consequence To Patient 9 9
No Patient Involvement 7 7
Superficial (First Degree) Burn 5 5
Burn, Thermal 5 5
Insufficient Information 5 5
Burn(s) 4 4
Endophthalmitis 2 2
Discomfort 2 2
Partial thickness (Second Degree) Burn 2 2
Patient Problem/Medical Problem 1 1
Inflammation 1 1
Injury 1 1
Blurred Vision 1 1
Eye Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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