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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, steam
Regulation Description Steam sterilizer.
Product CodeFLE
Regulation Number 880.6880
Device Class 2


Premarket Reviews
ManufacturerDecision
ASTELL SCIENTIFIC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BELIMED AG
  SUBSTANTIALLY EQUIVALENT 2
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET GMBH
  SUBSTANTIALLY EQUIVALENT 2
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 76 76
2017 63 63
2018 90 90
2019 91 91
2020 87 87
2021 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 97 97
Leak/Splash 73 73
Device Fell 53 53
Adverse Event Without Identified Device or Use Problem 52 52
Device Operates Differently Than Expected 24 24
Component Falling 17 17
Failure To Adhere Or Bond 12 12
Unstable 11 11
Insufficient Information 9 9
Appropriate Term/Code Not Available 7 7
Gas Leak 7 7
Pressure Problem 7 7
Labelling, Instructions for Use or Training Problem 6 6
Problem with Software Installation 6 6
Temperature Problem 5 5
Smoking 5 5
Detachment Of Device Component 5 5
Improper or Incorrect Procedure or Method 5 5
Defective Component 5 5
Device Alarm System 5 5
Circuit Failure 4 4
Moisture or Humidity Problem 4 4
Sharp Edges 4 4
Mechanical Problem 4 4
Device Emits Odor 4 4
Use of Device Problem 4 4
Device Handling Problem 4 4
Device Dislodged or Dislocated 3 3
Device Tipped Over 3 3
Device Slipped 3 3
Detachment of Device or Device Component 3 3
Overheating of Device 3 3
Melted 3 3
Collapse 3 3
Flaked 3 3
Device Contamination with Chemical or Other Material 3 3
Contamination 3 3
Loose or Intermittent Connection 3 3
Residue After Decontamination 2 2
Connection Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Unintended Movement 2 2
Crack 2 2
Device Reprocessing Problem 2 2
Fire 2 2
Loss of Power 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Fumes or Vapors 2 2
Human Factors Issue 2 2
Sparking 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Therapeutic or Diagnostic Output Failure 2 2
Protective Measures Problem 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Difficult to Open or Close 1 1
Missing Value Reason 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
No Flow 1 1
Packaging Problem 1 1
Defective Device 1 1
Problem with Sterilization 1 1
Material Fragmentation 1 1
Unintended Ejection 1 1
Air Leak 1 1
Break 1 1
Burst Container or Vessel 1 1
Explosion 1 1
Fail-Safe Did Not Operate 1 1
Scratched Material 1 1
Positioning Problem 1 1
Electrical Shorting 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Displays Incorrect Message 1 1
Unintended System Motion 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Sticking 1 1
Device Inoperable 1 1
Corroded 1 1
Material Erosion 1 1
Fail-Safe Design Failure 1 1
Accessory Incompatible 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 198 198
No Clinical Signs, Symptoms or Conditions 60 60
No Consequences Or Impact To Patient 57 57
Injury 48 48
Burn, Thermal 23 23
No Information 16 16
Insufficient Information 14 14
Burn(s) 12 12
Fall 10 10
Superficial (First Degree) Burn 5 5
No Patient Involvement 5 5
Pain 4 4
No Code Available 4 4
Laceration(s) 3 3
Unspecified Tissue Injury 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sprain 1 1
Neck Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Ear or Labyrinth Problem 1 1
Muscle/Tendon Damage 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Burning Sensation 1 1
Complaint, Ill-Defined 1 1
Missing Value Reason 1 1
Apnea 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fort Defiance Industries, LLC II Jul-10-2018
2 Skytron, Div. The KMW Group, Inc II Jun-13-2019
3 Steris Corporation II Dec-05-2019
4 Steris Corporation II Nov-29-2019
5 Steris Corporation II Feb-13-2019
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