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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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

MDR Year MDR Reports MDR Events
2019 11 11
2020 11 11
2021 20 20
2022 46 46
2023 19 19
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Activation 50 50
Adverse Event Without Identified Device or Use Problem 9 9
Self-Activation or Keying 9 9
Ventilation Problem in Device Environment 9 9
Noise, Audible 6 6
Electrical Shorting 6 6
Arcing of Electrodes 4 4
Smoking 4 4
Appropriate Term/Code Not Available 4 4
Intermittent Energy Output 4 4
Melted 3 3
Delivered as Unsterile Product 2 2
Device Emits Odor 2 2
Overheating of Device 2 2
Break 2 2
Decrease in Suction 2 2
Fire 2 2
Flaked 2 2
Structural Problem 2 2
Defective Device 2 2
Failure to Shut Off 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Activation 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
Arcing at Paddles 1 1
Material Integrity Problem 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
Electrical Power Problem 1 1
Fumes or Vapors 1 1
Defective Component 1 1
Failure to Calibrate 1 1
Fluid/Blood Leak 1 1
Unintended Power Up 1 1
Circuit Failure 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Premature Activation 1 1
Device Remains Activated 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
Insufficient Information 8 8
No Consequences Or Impact To Patient 6 6
No Patient Involvement 6 6
No Known Impact Or Consequence To Patient 6 6
Partial thickness (Second Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Rash 1 1
Scar Tissue 1 1
Burning Sensation 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Caustic/Chemical Burns 1 1
Full thickness (Third Degree) Burn 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
Burn(s) 1 1

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