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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
BELIMED AG
  SUBSTANTIALLY EQUIVALENT 2
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MILTON E PEDRAZZI D.D.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
REVOLUTIONARY SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SAUTER AG
  SUBSTANTIALLY EQUIVALENT 1
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K190062  STATCLAVE G4 Chamber Autoclave
  2.  K192910  STATClave G4 Chamber Autoclave
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER USA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 68 68
2016 76 76
2017 63 63
2018 90 90
2019 91 91
2020 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 91 91
Leak/Splash 74 74
Adverse Event Without Identified Device or Use Problem 51 51
Device Fell 41 41
Device Operates Differently Than Expected 30 30
Component Falling 22 22
Failure To Adhere Or Bond 12 12
Insufficient Information 11 11
Unstable 10 10
Moisture or Humidity Problem 7 7
Appropriate Term/Code Not Available 7 7
Noise, Audible 7 7
Detachment Of Device Component 6 6
Improper or Incorrect Procedure or Method 6 6
Smoking 6 6
Device Emits Odor 5 5
Defective Component 5 5
Device Alarm System 5 5
Wheel 5 5
Temperature Problem 5 5
Gas Leak 5 5
Device Handling Problem 4 4
Circuit Failure 4 4
Device Displays Incorrect Message 4 4
Sharp Edges 4 4
Mechanical Problem 4 4
Melted 3 3
Collapse 3 3
Device Subassembly 3 3
Unit 3 3
Seal 3 3
Overheating of Device 3 3
Device Slipped 3 3
Use of Device Problem 3 3
Contamination 3 3
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 3 3
Protective Measures Problem 2 2
Human Factors Issue 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Lock 2 2
Pressure Problem 2 2
Residue After Decontamination 2 2
Connection Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Contamination with Chemical or Other Material 2 2
Fire 2 2
Loss of Power 2 2
Fumes or Vapors 2 2
Device Tipped Over 2 2
Sparking 2 2
Scratched Material 2 2
Unintended Movement 2 2
Crack 2 2
Device Reprocessing Problem 2 2
Fail-Safe Did Not Operate 1 1
Unintended Ejection 1 1
Explosion 1 1
Air Leak 1 1
Break 1 1
Burst Container or Vessel 1 1
Patient-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Defective Device 1 1
Problem with Sterilization 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Device Contaminated During Manufacture or Shipping 1 1
Arcing 1 1
Reset Problem 1 1
Positioning Problem 1 1
Contamination /Decontamination Problem 1 1
Accessory Incompatible 1 1
Alarm 1 1
Valve(s) 1 1
Label 1 1
Latch 1 1
Increase in Pressure 1 1
Self-Activation or Keying 1 1
Sticking 1 1
Device Inoperable 1 1
Material Erosion 1 1
Fail-Safe Design Failure 1 1
Circuit Breaker 1 1
Missing Value Reason 1 1
Material Split, Cut or Torn 1 1
Mechanical Jam 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 239 239
No Consequences Or Impact To Patient 57 57
Injury 57 57
Burn, Thermal 22 22
No Information 17 17
Burn(s) 17 17
Fall 11 11
No Clinical Signs, Symptoms or Conditions 7 7
No Patient Involvement 5 5
Pain 5 5
No Code Available 4 4
Laceration(s) 3 3
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Sprain 1 1
Swelling 1 1
Neck Pain 1 1
Partial thickness (Second Degree) Burn 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
6 Steris Corporation III Nov-04-2015
7 Steris Corporation II Apr-30-2015
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