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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 264 264

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 768 768
Break 677 677
Connection Problem 259 259
Crack 242 242
Detachment of Device or Device Component 121 121
Adverse Event Without Identified Device or Use Problem 108 108
Mechanical Problem 81 81
Microbial Contamination of Device 77 77
Improper or Incorrect Procedure or Method 76 76
Leak/Splash 74 74
Use of Device Problem 72 72
Failure to Clean Adequately 57 57
Contamination 54 54
Insufficient Information 52 52
Fluid/Blood Leak 47 47
Failure to Disinfect 41 41
Device Handling Problem 41 41
Disconnection 35 35
Device Contamination with Chemical or Other Material 33 33
Component Missing 32 32
Contamination /Decontamination Problem 32 32
Fracture 30 30
Off-Label Use 27 27
Loose or Intermittent Connection 25 25
Fumes or Vapors 22 22
Material Integrity Problem 22 22
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
Use of Incorrect Control/Treatment Settings 15 15
Smoking 14 14
Restricted Flow rate 13 13
Device Operates Differently Than Expected 13 13
Output Problem 13 13
Maintenance Does Not Comply To Manufacturers Recommendations 12 12
Degraded 12 12
Device Alarm System 12 12
Defective Component 11 11
Chemical Problem 10 10
Electrical /Electronic Property Problem 10 10
Incomplete or Inadequate Connection 10 10
Material Split, Cut or Torn 9 9
Filling Problem 9 9
Chemical Spillage 9 9
Residue After Decontamination 9 9
Infusion or Flow Problem 9 9
No Flow 9 9
Mechanical Jam 8 8
Device Disinfection Or Sterilization Issue 8 8
Filtration Problem 8 8
Obstruction of Flow 8 8
Display or Visual Feedback Problem 8 8
Particulates 7 7
Misconnection 7 7
Communication or Transmission Problem 7 7
Device Displays Incorrect Message 6 6
Material Separation 6 6
Fire 6 6
Separation Problem 6 6
Device Difficult to Maintain 6 6
Ventilation Problem in Device Environment 5 5
Protective Measures Problem 5 5
Failure to Cycle 5 5
Device Emits Odor 5 5
Flushing Problem 5 5
Material Fragmentation 5 5
Facilities Issue 5 5
Human-Device Interface Problem 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 4 4
Lack of Maintenance Documentation or Guidelines 4 4
Difficult to Open or Close 4 4
Contamination of Device Ingredient or Reagent 4 4
Shipping Damage or Problem 4 4
Inadequate or Insufficient Training 4 4
False Alarm 4 4
Component Falling 4 4
Component Incompatible 3 3
Accessory Incompatible 3 3
Detachment Of Device Component 3 3
Image Display Error/Artifact 3 3
Labelling, Instructions for Use or Training Problem 3 3
Decrease in Pressure 3 3
Fitting Problem 3 3
Inadequate Filtration Process 3 3
Device Contamination With Biological Material 3 3
Programming Issue 3 3
Pressure Problem 2 2
Unintended Movement 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Sensing Problem 2 2
Electrical Shorting 2 2
Improper Flow or Infusion 2 2
Device Rinsing Issue 2 2
Expiration Date Error 2 2
Device Damaged Prior to Use 2 2
Component or Accessory Incompatibility 2 2
Device Difficult to Setup or Prepare 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2244 2244
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 33 33
No Code Available 28 28
Headache 26 26
Burn(s) 23 23
Unspecified Infection 19 19
Death 18 18
Exposure to Body Fluids 13 13
Pain 10 10
Complaint, Ill-Defined 9 9
Burning Sensation 8 8
Fungal Infection 8 8
Bacterial Infection 8 8
Fever 8 8
Skin Discoloration 7 7
Nausea 7 7
Itching Sensation 6 6
Respiratory Distress 6 6
Foreign Body In Patient 6 6
Chills 6 6
Dizziness 6 6
Sneezing 6 6
Urinary Frequency 5 5
Viral Infection 5 5
Caustic/Chemical Burns 5 5
Skin Irritation 5 5
Urinary Tract Infection 5 5
Irritation 5 5
Inflammation 4 4
Dyspnea 4 4
Eye Burn 4 4
Injury 4 4
Eye Pain 4 4
Sexually Transmitted Infection 4 4
Skin Inflammation/ Irritation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Sore Throat 3 3
Discomfort 3 3
Swelling 3 3
Chest Tightness/Pressure 3 3
Patient Problem/Medical Problem 3 3
Aspiration Pneumonitis 2 2
Electric Shock 2 2
Blood Loss 2 2
Tingling 2 2
Toxicity 2 2
Erythema 2 2
Eye Injury 2 2
Abrasion 2 2
Hepatitis 2 2
Vomiting 2 2
Drug Resistant Bacterial Infection 2 2
Unspecified Respiratory Problem 2 2
Unspecified Eye / Vision Problem 2 2
Test Result 1 1
Sprain 1 1
Scarring 1 1
Perforation 1 1
Rash 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Anaphylactic Shock 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Asthma 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Fall 1 1
Fungus 1 1
Gastritis 1 1
Conjunctivitis 1 1
Reaction 1 1
Malaise 1 1
Pharyngitis 1 1
Discharge 1 1
Infection, Indirect 1 1
Neck Pain 1 1
Cough 1 1
Bowel Perforation 1 1

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 Dec-22-2023
12 Steris Corporation III Nov-16-2020
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