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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
Product CodeFYD
Regulation Number 878.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NORTHGATE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 11 11
2020 11 11
2021 20 20
2022 46 46
2023 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Activation 48 48
Self-Activation or Keying 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Ventilation Problem in Device Environment 8 8
Noise, Audible 5 5
Electrical Shorting 5 5
Appropriate Term/Code Not Available 4 4
Intermittent Energy Output 4 4
Smoking 4 4
Arcing of Electrodes 3 3
Melted 3 3
Delivered as Unsterile Product 2 2
Device Emits Odor 2 2
Overheating of Device 2 2
Fire 2 2
Flaked 2 2
Break 2 2
Decrease in Suction 2 2
Structural Problem 2 2
Suction Problem 2 2
Defective Device 2 2
Failure to Shut Off 2 2
Output Problem 2 2
Device Remains Activated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Activation Failure 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Electrical Power Problem 1 1
No Audible Prompt/Feedback 1 1
Improper or Incorrect Procedure or Method 1 1
Fumes or Vapors 1 1
Defective Component 1 1
Failure to Calibrate 1 1
Unintended Power Up 1 1
False Alarm 1 1
Arcing at Paddles 1 1
Circuit Failure 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Premature Activation 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 9 9
Insufficient Information 8 8
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 6 6
Partial thickness (Second Degree) Burn 2 2
Burn(s) 2 2
Hemorrhage/Bleeding 2 2
Rash 1 1
Burning Sensation 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Caustic/Chemical Burns 1 1
No Information 1 1
No Code Available 1 1
Blister 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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