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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, cleaning, for endoscope
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFEB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS (ASP)
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 62 62
2020 426 426
2021 575 575
2022 607 607
2023 998 998
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 667 667
Break 594 594
Connection Problem 243 243
Crack 239 239
Detachment of Device or Device Component 108 108
Mechanical Problem 75 75
Microbial Contamination of Device 64 64
Use of Device Problem 58 58
Leak/Splash 57 57
Failure to Clean Adequately 53 53
Contamination 47 47
Fluid/Blood Leak 39 39
Adverse Event Without Identified Device or Use Problem 36 36
Device Handling Problem 36 36
Failure to Disinfect 35 35
Disconnection 33 33
Component Missing 29 29
Improper or Incorrect Procedure or Method 25 25
Device Contamination with Chemical or Other Material 24 24
Loose or Intermittent Connection 23 23
Fracture 22 22
Material Integrity Problem 22 22
Misassembly During Maintenance/Repair 21 21
No Apparent Adverse Event 17 17
Defective Device 17 17
Contamination /Decontamination Problem 14 14
Output Problem 13 13
Restricted Flow rate 12 12
Degraded 11 11
Device Alarm System 11 11
Smoking 11 11
Insufficient Information 11 11
Defective Component 11 11
Incomplete or Inadequate Connection 10 10
Material Split, Cut or Torn 9 9
Infusion or Flow Problem 9 9
Electrical /Electronic Property Problem 9 9
Filling Problem 9 9
Display or Visual Feedback Problem 8 8
Filtration Problem 8 8
Fumes or Vapors 8 8
No Flow 7 7
Residue After Decontamination 7 7
Obstruction of Flow 7 7
Particulates 7 7
Off-Label Use 7 7
Mechanical Jam 6 6
Communication or Transmission Problem 6 6
Separation Problem 6 6
Device Difficult to Maintain 6 6
Protective Measures Problem 5 5
Material Fragmentation 5 5
Use of Incorrect Control/Treatment Settings 5 5
Failure to Cycle 4 4
False Alarm 4 4
Flushing Problem 4 4
Fire 4 4
Material Separation 4 4
Inadequate or Insufficient Training 4 4
Device Displays Incorrect Message 4 4
Difficult to Open or Close 4 4
Lack of Maintenance Documentation or Guidelines 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 3 3
Appropriate Term/Code Not Available 3 3
Fitting Problem 3 3
Decrease in Pressure 3 3
Misconnection 3 3
Image Display Error/Artifact 3 3
Labelling, Instructions for Use or Training Problem 3 3
Inaccurate Flow Rate 2 2
Material Erosion 2 2
Backflow 2 2
Corroded 2 2
Complete Blockage 2 2
Device Emits Odor 2 2
Device Difficult to Setup or Prepare 2 2
Device Damaged Prior to Use 2 2
Shipping Damage or Problem 2 2
Product Quality Problem 2 2
Unintended Movement 2 2
Ventilation Problem in Device Environment 2 2
Component or Accessory Incompatibility 2 2
Expiration Date Error 2 2
Chemical Problem 2 2
Device Sensing Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Unsafe to Use in Environment 1 1
Malposition of Device 1 1
Ambient Temperature Problem 1 1
Calibration Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Compatibility Problem 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2041 2041
No Patient Involvement 294 294
No Consequences Or Impact To Patient 153 153
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 30 30
Chemical Exposure 25 25
Headache 19 19
Burn(s) 15 15
Unspecified Infection 14 14
Fever 7 7
Pain 6 6
Urinary Tract Infection 5 5
Chills 5 5
Viral Infection 5 5
Urinary Frequency 5 5
Foreign Body In Patient 5 5
Sexually Transmitted Infection 4 4
Eye Pain 4 4
Eye Burn 4 4
Dizziness 4 4
Dyspnea 4 4
Inflammation 3 3
Caustic/Chemical Burns 3 3
Discomfort 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Aspiration Pneumonitis 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Skin Inflammation/ Irritation 2 2
Drug Resistant Bacterial Infection 2 2
Sore Throat 2 2
Vomiting 2 2
Hepatitis 2 2
Erythema 2 2
Bacterial Infection 2 2
Bruise/Contusion 1 1
Abrasion 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Eye Injury 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Fungus 1 1
Irritation 1 1
Itching Sensation 1 1
Nausea 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Infection, Indirect 1 1
Chest Tightness/Pressure 1 1
Injury 1 1
Cough 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-07-2024
2 Olympus Corporation of the Americas II Aug-23-2023
3 Olympus Corporation of the Americas II Aug-04-2023
4 Olympus Corporation of the Americas II Feb-11-2022
5 Steris Corporation II Dec-22-2023
6 Steris Corporation III Nov-16-2020
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