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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
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ASTELL SCIENTIFIC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BELIMED AG
  SUBSTANTIALLY EQUIVALENT 2
BELIMED SAUTER AG
  SUBSTANTIALLY EQUIVALENT 2
BELIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CONSOLIDATED MACHINE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ENBIO GROUP AG
  SUBSTANTIALLY EQUIVALENT 2
FORT DEFIANCE INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
FORT DEFIANCE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETINGE SOURCING LLC
  SUBSTANTIALLY EQUIVALENT 3
GETINGE SOURCING, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAQUET GMBH
  SUBSTANTIALLY EQUIVALENT 3
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MILTON E PEDRAZZI D.D.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS STERILIZER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
PRIMUS STERILIZER COMPANY, LLC.
  SUBSTANTIALLY EQUIVALENT 2
REVOLUTIONARY SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SAKURA SEIKI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SAUTER AG
  SUBSTANTIALLY EQUIVALENT 2
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHINVA MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STEELCO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
TUTTNAUER CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER LTD.
  SUBSTANTIALLY EQUIVALENT 4
TUTTNAUER U.S.A CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
TUTTNAUER USA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 113 113
2015 68 68
2016 76 76
2017 63 63
2018 90 90
2019 91 91
2020 87 87
2021 81 81
2022 70 70
2023 66 66
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 177 177
Fluid/Blood Leak 148 148
Adverse Event Without Identified Device or Use Problem 62 62
Device Fell 58 58
Device Operates Differently Than Expected 37 37
Device Tipped Over 28 28
Component Falling 28 28
Insufficient Information 27 27
Detachment of Device or Device Component 23 23
Use of Device Problem 19 19
Noise, Audible 14 14
Unstable 12 12
Failure To Adhere Or Bond 12 12
Smoking 10 10
Improper or Incorrect Procedure or Method 9 9
Device Displays Incorrect Message 9 9
Gas/Air Leak 9 9
Pressure Problem 9 9
Problem with Software Installation 8 8
Appropriate Term/Code Not Available 8 8
Unintended Movement 8 8
Sparking 8 8
Detachment Of Device Component 7 7
Mechanical Problem 7 7
Moisture or Humidity Problem 7 7
Device Handling Problem 6 6
Sharp Edges 6 6
Device Emits Odor 6 6
Labelling, Instructions for Use or Training Problem 6 6
Loose or Intermittent Connection 5 5
Device Alarm System 5 5
Break 5 5
Defective Component 5 5
Temperature Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Protective Measures Problem 4 4
Positioning Problem 4 4
Fumes or Vapors 4 4
Device Dislodged or Dislocated 4 4
Circuit Failure 4 4
Device Reprocessing Problem 4 4
Contamination 4 4
Fire 4 4
Flaked 4 4
Unintended System Motion 4 4
Overheating of Device 4 4
Melted 3 3
Crack 3 3
Collapse 3 3
Failure to Align 3 3
Failure to Power Up 3 3
Product Quality Problem 3 3
Device Slipped 3 3
Defective Device 3 3
Human Factors Issue 2 2
Packaging Problem 2 2
Mechanical Jam 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Residue After Decontamination 2 2
Problem with Sterilization 2 2
Difficult to Open or Close 2 2
Device Disinfection Or Sterilization Issue 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Air Leak 2 2
Loss of Power 2 2
Unintended Ejection 2 2
Material Fragmentation 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Accessory Incompatible 1 1
Thermal Decomposition of Device 1 1
Burst Container or Vessel 1 1
Positioning Failure 1 1
Material Discolored 1 1
Disconnection 1 1
Material Erosion 1 1
Fail-Safe Design Failure 1 1
Corroded 1 1
Electrical Shorting 1 1
Arcing 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Sticking 1 1
Device Inoperable 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Shipping Damage or Problem 1 1
Self-Activation or Keying 1 1
Increase in Pressure 1 1
Physical Resistance/Sticking 1 1
Explosion 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 315 315
No Clinical Signs, Symptoms or Conditions 163 163
No Consequences Or Impact To Patient 76 76
Injury 66 66
Burn(s) 39 39
Insufficient Information 29 29
Burn, Thermal 24 24
No Information 21 21
Pain 19 19
Fall 16 16
No Code Available 8 8
Laceration(s) 7 7
No Patient Involvement 6 6
Superficial (First Degree) Burn 6 6
Bruise/Contusion 3 3
Partial thickness (Second Degree) Burn 3 3
Bone Fracture(s) 3 3
Headache 3 3
Unspecified Infection 2 2
Abrasion 2 2
Unspecified Tissue Injury 2 2
Skin Tears 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Neck Pain 1 1
Swelling/ Edema 1 1
Missing Value Reason 1 1
Unspecified Ear or Labyrinth Problem 1 1
Muscle/Tendon Damage 1 1
Apnea 1 1
Ecchymosis 1 1
Inflammation 1 1
Nausea 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Respiratory Distress 1 1
Sprain 1 1
Swelling 1 1
Tachycardia 1 1
Burning Sensation 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 Midmark Corportation II Jan-11-2012
4 Scican Ltd. II Aug-03-2023
5 Skytron, Div. The KMW Group, Inc II Jun-13-2019
6 Steris Corporation II Dec-05-2019
7 Steris Corporation II Nov-29-2019
8 Steris Corporation II Feb-13-2019
9 Steris Corporation III Nov-04-2015
10 Steris Corporation II Apr-30-2015
11 Steris Corporation II Dec-11-2013
12 Steris Corporation II Mar-06-2013
13 Steris Corporation II May-11-2012
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