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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
2026 1 1

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
Suction 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
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 9 9
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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