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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, exhaust, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Product CodeFYD
Regulation Number 878.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURNIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 46 46
2023 19 19
2024 11 11
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Activation 62 62
Adverse Event Without Identified Device or Use Problem 13 13
Noise, Audible 9 9
Ventilation Problem in Device Environment 9 9
Arcing of Electrodes 6 6
Appropriate Term/Code Not Available 6 6
Electrical Shorting 6 6
Intermittent Energy Output 4 4
Self-Activation or Keying 4 4
Fire 3 3
Break 2 2
Flaked 2 2
Smoking 2 2
Decrease in Suction 2 2
Structural Problem 2 2
Melted 2 2
Protective Measures Problem 2 2
Failure to Calibrate 2 2
Temperature Problem 1 1
Premature Activation 1 1
Fluid/Blood Leak 1 1
Arcing at Paddles 1 1
Device Displays Incorrect Message 1 1
Overheating of Device 1 1
Human-Device Interface Problem 1 1
Suction Problem 1 1
Computer Software Problem 1 1
Activation Failure 1 1
Detachment of Device or Device Component 1 1
Failure to Fire 1 1
Material Separation 1 1
Device Emits Odor 1 1
Contamination /Decontamination Problem 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Unintended Electrical Shock 1 1
Electrical Power Problem 1 1
Unintended Power Up 1 1
Physical Resistance/Sticking 1 1
Communication or Transmission Problem 1 1
Sparking 1 1
Fumes or Vapors 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Insufficient Information 8 8
Partial thickness (Second Degree) Burn 5 5
Burn(s) 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Superficial (First Degree) Burn 1 1
Blister 1 1
Foreign Body In Patient 1 1
Rash 1 1
Burning Sensation 1 1
Scar Tissue 1 1
Unspecified Tissue Injury 1 1
Caustic/Chemical Burns 1 1
Full thickness (Third Degree) Burn 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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