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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
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS (ASP)
  SUBSTANTIALLY EQUIVALENT 2
CUSTOM ULTRASONICS
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ULTRASONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LANGFORD IC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS INC
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
MINNTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 48 48
2015 92 92
2016 103 103
2017 69 69
2018 88 88
2019 62 62
2020 426 426
2021 575 575
2022 607 607
2023 998 998
2024 647 647

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 842 842
Break 819 819
Connection Problem 299 299
Crack 248 248
Detachment of Device or Device Component 145 145
Adverse Event Without Identified Device or Use Problem 111 111
Microbial Contamination of Device 89 89
Leak/Splash 86 86
Mechanical Problem 83 83
Failure to Clean Adequately 79 79
Improper or Incorrect Procedure or Method 79 79
Use of Device Problem 74 74
Insufficient Information 54 54
Contamination 54 54
Fluid/Blood Leak 47 47
Device Handling Problem 44 44
Failure to Disinfect 43 43
Component Missing 40 40
Disconnection 36 36
Device Contamination with Chemical or Other Material 33 33
Contamination /Decontamination Problem 32 32
Fumes or Vapors 31 31
Fracture 30 30
Off-Label Use 27 27
Loose or Intermittent Connection 25 25
Material Integrity Problem 23 23
Appropriate Term/Code Not Available 22 22
Misassembly During Maintenance/Repair 21 21
No Apparent Adverse Event 19 19
Defective Device 18 18
Device Inoperable 16 16
Output Problem 15 15
Incomplete or Inadequate Connection 15 15
Use of Incorrect Control/Treatment Settings 15 15
Restricted Flow rate 14 14
Smoking 14 14
Device Alarm System 13 13
Defective Component 13 13
Device Operates Differently Than Expected 13 13
Communication or Transmission Problem 12 12
Degraded 12 12
Maintenance Does Not Comply To Manufacturers Recommendations 12 12
Material Split, Cut or Torn 11 11
Infusion or Flow Problem 11 11
Filling Problem 11 11
Chemical Problem 10 10
Electrical /Electronic Property Problem 10 10
Misconnection 9 9
Residue After Decontamination 9 9
Chemical Spillage 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2613 2613
No Patient Involvement 302 302
No Known Impact Or Consequence To Patient 253 253
No Consequences Or Impact To Patient 167 167
Chemical Exposure 101 101
No Information 46 46
Insufficient Information 34 34
Headache 28 28
No Code Available 28 28
Burn(s) 26 26
Unspecified Infection 19 19
Death 18 18
Exposure to Body Fluids 13 13
Pain 11 11
Burning Sensation 10 10
Complaint, Ill-Defined 9 9
Fungal Infection 8 8
Nausea 8 8
Bacterial Infection 8 8
Fever 8 8
Foreign Body In Patient 7 7
Skin Discoloration 7 7
Respiratory Distress 6 6
Dizziness 6 6
Dyspnea 6 6
Itching Sensation 6 6
Sneezing 6 6
Chills 6 6
Skin Irritation 5 5
Urinary Tract Infection 5 5
Urinary Frequency 5 5
Caustic/Chemical Burns 5 5
Viral Infection 5 5
Irritation 5 5
Eye Pain 4 4
Sore Throat 4 4
Inflammation 4 4
Sexually Transmitted Infection 4 4
Vomiting 4 4
Eye Burn 4 4
Injury 4 4
Patient Problem/Medical Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Discomfort 3 3
Swelling 3 3
Chest Tightness/Pressure 3 3
Asthma 3 3
Skin Inflammation/ Irritation 3 3
Hepatitis 2 2
Electric Shock 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Jan-09-2017
2 Advanced Sterilization Products II Jun-05-2015
3 Advanced Sterilization Products II Apr-18-2013
4 Advanced Sterilization Products II Apr-15-2013
5 Minntech Corp II Aug-12-2010
6 Olympus Corporation of the Americas II Feb-07-2024
7 Olympus Corporation of the Americas II Aug-23-2023
8 Olympus Corporation of the Americas II Aug-04-2023
9 Olympus Corporation of the Americas II Feb-11-2022
10 Olympus Corporation of the Americas II Oct-19-2016
11 Steris Corporation II Aug-08-2024
12 Steris Corporation II Dec-22-2023
13 Steris Corporation III Nov-16-2020
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