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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
BELIMED AG
  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 2
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PRIMUS STERILIZER COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
SCICAN LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHINVA MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STEELCO S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
STURDY INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
TUTTNAUER LTD.
  SUBSTANTIALLY EQUIVALENT 4
TUTTNAUER U.S.A CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
W&H STERILIZATION S.R.L.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 91 91
2020 87 87
2021 81 81
2022 70 70
2023 66 66
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 101 101
Fluid/Blood Leak 58 58
Device Fell 54 54
Adverse Event Without Identified Device or Use Problem 30 30
Device Tipped Over 26 26
Detachment of Device or Device Component 22 22
Use of Device Problem 15 15
Insufficient Information 13 13
Problem with Software Installation 8 8
Pressure Problem 7 7
Sharp Edges 6 6
Unstable 6 6
Labelling, Instructions for Use or Training Problem 6 6
Device Alarm System 5 5
Device Handling Problem 5 5
Unintended Movement 4 4
Gas/Air Leak 4 4
Device Dislodged or Dislocated 4 4
Fire 4 4
Flaked 4 4
Unintended System Motion 4 4
Smoking 4 4
Defective Device 3 3
Product Quality Problem 3 3
Device Slipped 3 3
Loose or Intermittent Connection 3 3
Mechanical Problem 3 3
Protective Measures Problem 3 3
Temperature Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Moisture or Humidity Problem 2 2
Difficult to Open or Close 2 2
Sparking 2 2
Positioning Problem 2 2
Noise, Audible 2 2
No Apparent Adverse Event 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Overheating of Device 2 2
Failure to Align 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 1 1
Structural Problem 1 1
Particulates 1 1
Accessory Incompatible 1 1
Shipping Damage or Problem 1 1
Nonstandard Device 1 1
Material Fragmentation 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Contamination 1 1
Corroded 1 1
Crack 1 1
Failure to Cycle 1 1
Positioning Failure 1 1
Unintended Ejection 1 1
Unintended Electrical Shock 1 1
Explosion 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Difficult to Maintain 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
No Flow 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 175 175
No Known Impact Or Consequence To Patient 69 69
No Consequences Or Impact To Patient 38 38
Insufficient Information 29 29
Burn(s) 23 23
Injury 18 18
Burn, Thermal 14 14
Pain 13 13
Fall 7 7
Laceration(s) 5 5
Superficial (First Degree) Burn 4 4
No Information 3 3
Bone Fracture(s) 3 3
Bruise/Contusion 3 3
Abrasion 2 2
Unspecified Infection 2 2
Skin Tears 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Unspecified Ear or Labyrinth Problem 1 1
Muscle/Tendon Damage 1 1
No Patient Involvement 1 1
Discomfort 1 1
Inflammation 1 1
Headache 1 1
Ecchymosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fort Defiance Industries, LLC II Oct-16-2021
2 Scican Ltd. II Aug-03-2023
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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