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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
2017 20 20
2018 12 12
2019 29 29
2020 33 33
2021 20 20
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 22 22
Detachment of Device or Device Component 18 18
Break 14 14
Temperature Problem 14 14
Melted 11 11
Fracture 8 8
Material Integrity Problem 7 7
Thermal Decomposition of Device 6 6
Device Emits Odor 5 5
Material Separation 5 5
Smoking 4 4
Use of Device Problem 4 4
Excessive Heating 4 4
Device Operates Differently Than Expected 3 3
Device Dislodged or Dislocated 2 2
Dull, Blunt 2 2
Material Fragmentation 2 2
Crack 2 2
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Disconnection 1 1
Fire 1 1
Circuit Failure 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Component Incompatible 1 1
Difficult to Insert 1 1
Inability to Irrigate 1 1
Leak/Splash 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Difficult or Delayed Activation 1 1
Defective Device 1 1
Sparking 1 1
Contamination /Decontamination Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Material Deformation 1 1
Device Slipped 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 36 36
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 24 24
Burn(s) 8 8
No Patient Involvement 7 7
Burn, Thermal 6 6
Superficial (First Degree) Burn 5 5
Injury 3 3
No Code Available 3 3
Insufficient Information 2 2
Discomfort 2 2
Skin Discoloration 1 1
Patient Problem/Medical Problem 1 1
Breast Discomfort/Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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