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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, steam
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 1
ENBIO GROUP AG
  SUBSTANTIALLY EQUIVALENT 2
FORT DEFIANCE INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
MAQUET GMBH
  SUBSTANTIALLY EQUIVALENT 3
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 4
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER LTD.
  SUBSTANTIALLY EQUIVALENT 2
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 63 63
2018 90 90
2019 91 91
2020 87 87
2021 81 81
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 87 87
Leak/Splash 70 70
Device Fell 56 56
Adverse Event Without Identified Device or Use Problem 51 51
Device Operates Differently Than Expected 13 13
Component Falling 11 11
Unstable 10 10
Detachment of Device or Device Component 10 10
Device Tipped Over 8 8
Failure To Adhere Or Bond 8 8
Insufficient Information 8 8
Gas Leak 7 7
Pressure Problem 7 7
Problem with Software Installation 6 6
Labelling, Instructions for Use or Training Problem 6 6
Smoking 5 5
Device Alarm System 5 5
Temperature Problem 5 5
Defective Component 5 5
Circuit Failure 4 4
Contamination 4 4
Use of Device Problem 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 4 4
Appropriate Term/Code Not Available 4 4
Sharp Edges 4 4
Device Handling Problem 3 3
Flaked 3 3
Collapse 3 3
Detachment Of Device Component 3 3
Device Slipped 3 3
Device Dislodged or Dislocated 3 3
Device Contamination with Chemical or Other Material 3 3
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Moisture or Humidity Problem 2 2
Difficult to Open or Close 2 2
Defective Device 2 2
Device Disinfection Or Sterilization Issue 2 2
Residue After Decontamination 2 2
Sparking 2 2
Fire 2 2
Melted 2 2
Device Emits Odor 2 2
Overheating of Device 2 2
Loss of Power 2 2
Improper or Incorrect Procedure or Method 2 2
Material Separation 2 2
Material Puncture/Hole 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Fail-Safe Did Not Operate 1 1
Explosion 1 1
Product Quality Problem 1 1
Problem with Sterilization 1 1
Increase in Pressure 1 1
Unintended System Motion 1 1
Nonstandard Device 1 1
Material Fragmentation 1 1
Corroded 1 1
Crack 1 1
Material Erosion 1 1
Unintended Ejection 1 1
Device Reprocessing Problem 1 1
Accessory Incompatible 1 1
Thermal Decomposition of Device 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Electrical Shorting 1 1
Naturally Worn 1 1
No Flow 1 1
Device Contaminated During Manufacture or Shipping 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Device Difficult to Maintain 1 1
Packaging Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 150 150
No Clinical Signs, Symptoms or Conditions 85 85
No Consequences Or Impact To Patient 52 52
Injury 37 37
Burn, Thermal 22 22
Insufficient Information 21 21
No Information 14 14
Burn(s) 13 13
Fall 9 9
Laceration(s) 4 4
Pain 4 4
No Code Available 4 4
No Patient Involvement 3 3
Superficial (First Degree) Burn 3 3
Patient Problem/Medical Problem 2 2
Bone Fracture(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Unspecified Ear or Labyrinth Problem 1 1
Muscle/Tendon Damage 1 1
Abrasion 1 1
Unspecified Infection 1 1
Ecchymosis 1 1
Respiratory Distress 1 1
Sprain 1 1
Burning Sensation 1 1
Neck Pain 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fort Defiance Industries, LLC II Oct-16-2021
2 Fort Defiance Industries, LLC II Jul-10-2018
3 Skytron, Div. The KMW Group, Inc II Jun-13-2019
4 Steris Corporation II Dec-05-2019
5 Steris Corporation II Nov-29-2019
6 Steris Corporation II Feb-13-2019
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