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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 849 849

Device Problems MDRs with this Device Problem Events in those MDRs
Break 891 891
Device Reprocessing Problem 844 844
Connection Problem 313 313
Crack 249 249
Detachment of Device or Device Component 159 159
Leak/Splash 88 88
Failure to Clean Adequately 86 86
Mechanical Problem 79 79
Microbial Contamination of Device 78 78
Use of Device Problem 66 66
Contamination 47 47
Disconnection 43 43
Component Missing 43 43
Adverse Event Without Identified Device or Use Problem 41 41
Fluid/Blood Leak 39 39
Device Handling Problem 39 39
Failure to Disinfect 39 39
Improper or Incorrect Procedure or Method 33 33
Fracture 30 30
Loose or Intermittent Connection 26 26
Device Contamination with Chemical or Other Material 24 24
Material Integrity Problem 24 24
Misassembly During Maintenance/Repair 21 21
Output Problem 20 20
Defective Device 18 18
Insufficient Information 18 18
Fumes or Vapors 17 17
No Apparent Adverse Event 17 17
Restricted Flow rate 16 16
Incomplete or Inadequate Connection 15 15
Degraded 14 14
Contamination /Decontamination Problem 14 14
Defective Component 14 14
Smoking 14 14
Communication or Transmission Problem 13 13
Device Alarm System 12 12
Infusion or Flow Problem 11 11
Filling Problem 11 11
Material Split, Cut or Torn 11 11
Electrical /Electronic Property Problem 9 9
Filtration Problem 9 9
Display or Visual Feedback Problem 8 8
Obstruction of Flow 8 8
Backflow 8 8
Particulates 7 7
Material Separation 7 7
Residue After Decontamination 7 7
Separation Problem 7 7
No Flow 7 7
Off-Label Use 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2808 2808
No Patient Involvement 294 294
No Consequences Or Impact To Patient 153 153
No Known Impact Or Consequence To Patient 77 77
Insufficient Information 34 34
Chemical Exposure 25 25
Headache 25 25
Burn(s) 25 25
Unspecified Infection 14 14
Pain 8 8
Fever 7 7
Dyspnea 6 6
Foreign Body In Patient 6 6
Urinary Tract Infection 5 5
Chills 5 5
Viral Infection 5 5
Urinary Frequency 5 5
Sore Throat 4 4
Dizziness 4 4
Vomiting 4 4
Eye Pain 4 4
Sexually Transmitted Infection 4 4
Eye Burn 4 4
Caustic/Chemical Burns 3 3
No Information 3 3
Skin Inflammation/ Irritation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Burning Sensation 3 3
Discomfort 3 3
Inflammation 3 3
Erythema 2 2
Asthma 2 2
Bacterial Infection 2 2
Bruise/Contusion 2 2
Skin Discoloration 2 2
Hepatitis 2 2
Drug Resistant Bacterial Infection 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Aspiration Pneumonitis 2 2
Nausea 2 2
Cough 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
Injury 1 1
Chest Tightness/Pressure 1 1
Infection, Indirect 1 1
Death 1 1
Abdominal Pain 1 1
Abrasion 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 Aug-08-2024
6 Steris Corporation II Dec-22-2023
7 Steris Corporation III Nov-16-2020
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