• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
CONSOLIDATED MACHINE CORP.
  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
SHINVA MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER LTD.
  SUBSTANTIALLY EQUIVALENT 3
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 63 63
2018 90 90
2019 91 91
2020 87 87
2021 81 81
2022 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 87 87
Leak/Splash 86 86
Device Fell 57 57
Adverse Event Without Identified Device or Use Problem 51 51
Device Tipped Over 18 18
Detachment of Device or Device Component 14 14
Insufficient Information 13 13
Device Operates Differently Than Expected 13 13
Component Falling 11 11
Unstable 10 10
Failure To Adhere Or Bond 8 8
Pressure Problem 7 7
Gas/Air Leak 7 7
Problem with Software Installation 6 6
Use of Device Problem 6 6
Labelling, Instructions for Use or Training Problem 6 6
Smoking 5 5
Temperature Problem 5 5
Device Alarm System 5 5
Defective Component 5 5
Contamination 4 4
Circuit Failure 4 4
Loose or Intermittent Connection 4 4
Sharp Edges 4 4
Appropriate Term/Code Not Available 4 4
Mechanical Problem 4 4
Collapse 3 3
Device Slipped 3 3
Defective Device 3 3
Noise, Audible 3 3
Device Dislodged or Dislocated 3 3
Flaked 3 3
Detachment Of Device Component 3 3
Improper or Incorrect Procedure or Method 3 3
Product Quality Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Unintended Movement 3 3
Protective Measures Problem 3 3
Device Handling Problem 3 3
Sparking 3 3
Fire 2 2
Device Emits Odor 2 2
Loss of Power 2 2
Material Separation 2 2
Unintended System Motion 2 2
Residue After Decontamination 2 2
Device Disinfection Or Sterilization Issue 2 2
Moisture or Humidity Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Difficult to Open or Close 2 2
Material Split, Cut or Torn 2 2
Failure to Align 2 2
Overheating of Device 2 2
Material Puncture/Hole 2 2
Melted 2 2
Nonstandard Device 1 1
Crack 1 1
Unintended Ejection 1 1
Deformation Due to Compressive Stress 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Naturally Worn 1 1
No Flow 1 1
Packaging Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Positioning Problem 1 1
Scratched Material 1 1
Device Difficult to Maintain 1 1
Explosion 1 1
Increase in Pressure 1 1
Thermal Decomposition of Device 1 1
Material Erosion 1 1
Problem with Sterilization 1 1
Material Fragmentation 1 1
Device Reprocessing Problem 1 1
Positioning Failure 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Physical Resistance/Sticking 1 1
Fail-Safe Did Not Operate 1 1
Device Contaminated During Manufacture or Shipping 1 1
Electrical Shorting 1 1
Corroded 1 1
Accessory Incompatible 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 117 117
No Consequences Or Impact To Patient 52 52
Injury 37 37
Burn, Thermal 22 22
Insufficient Information 22 22
Burn(s) 17 17
No Information 14 14
Fall 10 10
Pain 6 6
Laceration(s) 4 4
Superficial (First Degree) Burn 4 4
No Code Available 4 4
No Patient Involvement 3 3
Unspecified Tissue Injury 2 2
Bone Fracture(s) 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abrasion 1 1
Unspecified Ear or Labyrinth Problem 1 1
Ecchymosis 1 1
Swelling/ Edema 1 1
Unspecified Infection 1 1
Respiratory Distress 1 1
Burning Sensation 1 1
Discomfort 1 1
Sprain 1 1
Neck Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Muscle/Tendon Damage 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
-
-