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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
  1.  K170228  Belimed Steam Sterilizer MST-H TOP 5000
  2.  K191896  Belimed Steam Sterilizer MST-H TOP 5000
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
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
Improper or Incorrect Procedure or Method 6 6
Smoking 6 6
Detachment Of Device Component 6 6
Device Emits Odor 5 5
Device Alarm System 5 5
Defective Component 5 5
Gas Leak 5 5
Temperature Problem 5 5
Wheel 5 5
Device Handling Problem 4 4
Sharp Edges 4 4
Device Displays Incorrect Message 4 4
Circuit Failure 4 4
Mechanical Problem 4 4
Melted 3 3
Use of Device Problem 3 3
Overheating of Device 3 3
Collapse 3 3
Contamination 3 3
Seal 3 3
Detachment of Device or Device Component 3 3
Device Slipped 3 3
Device Dislodged or Dislocated 3 3
Device Subassembly 3 3
Unit 3 3
Scratched Material 2 2
Connection Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Human Factors Issue 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Device Tipped Over 2 2
Fumes or Vapors 2 2
Residue After Decontamination 2 2
Device Disinfection Or Sterilization Issue 2 2
Sparking 2 2
Lock 2 2
Crack 2 2
Device Reprocessing Problem 2 2
Loss of Power 2 2
Fire 2 2
Loose or Intermittent Connection 2 2
Increase in Pressure 1 1
Self-Activation or Keying 1 1
Problem with Sterilization 1 1
Sticking 1 1
Device Inoperable 1 1
Alarm 1 1
Material Erosion 1 1
Fail-Safe Design Failure 1 1
Unintended Ejection 1 1
Accessory Incompatible 1 1
Air Leak 1 1
Valve(s) 1 1
Label 1 1
Latch 1 1
Break 1 1
Burst Container or Vessel 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Difficult to Open or Close 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Arcing 1 1
Defective Device 1 1
Reset Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Circuit Breaker 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
No Flow 1 1
Missing Value Reason 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Explosion 1 1
Material Split, Cut or Torn 1 1
Fail-Safe Did Not Operate 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
Burn(s) 17 17
No Information 17 17
Fall 11 11
No Clinical Signs, Symptoms or Conditions 7 7
Pain 5 5
No Patient Involvement 5 5
No Code Available 4 4
Laceration(s) 3 3
Superficial (First Degree) Burn 2 2
Patient Problem/Medical Problem 2 2
Neck Pain 1 1
Complaint, Ill-Defined 1 1
Apnea 1 1
Headache 1 1
Respiratory Distress 1 1
Sprain 1 1
Swelling 1 1
Tachycardia 1 1
Burning Sensation 1 1
Missing Value Reason 1 1
Partial thickness (Second Degree) Burn 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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