• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device accessories, cleaning, for endoscope
Regulation Description Endoscope and accessories.
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
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 103 103
2017 69 69
2018 88 88
2019 62 62
2020 426 426
2021 156 156

Device Problems MDRs with this Device Problem Events in those MDRs
Break 153 153
Crack 133 133
Device Reprocessing Problem 83 83
Adverse Event Without Identified Device or Use Problem 77 77
Mechanical Problem 47 47
Improper or Incorrect Procedure or Method 40 40
Use of Device Problem 38 38
Insufficient Information 35 35
Microbial Contamination of Device 29 29
Device Handling Problem 19 19
Fumes or Vapors 17 17
Contamination /Decontamination Problem 16 16
Off-Label Use 16 16
Fluid Leak 16 16
Leak/Splash 14 14
Device Contamination with Chemical or Other Material 14 14
Connection Problem 13 13
Defective Device 12 12
Contamination 12 12
Maintenance Does Not Comply To Manufacturers Recommendations 12 12
Use of Incorrect Control Settings 10 10
Device Alarm System 10 10
Failure to Disinfect 10 10
Residue After Decontamination 9 9
Chemical Problem 9 9
Chemical Spillage 9 9
No Apparent Adverse Event 9 9
Device Inoperable 7 7
Component Missing 6 6
Failure to Clean Adequately 6 6
Appropriate Term/Code Not Available 5 5
Device Operates Differently Than Expected 5 5
Fracture 5 5
Restricted Flow rate 4 4
Component Falling 4 4
Degraded 4 4
Inadequate or Insufficient Training 4 4
Facilities Issue 4 4
Filtration Problem 4 4
Ventilation Problem in Device Environment 4 4
Misassembly During Maintenance/Repair 4 4
Infusion or Flow Problem 3 3
Detachment of Device or Device Component 3 3
Defective Component 3 3
Inadequate Filtration Process 3 3
Device Displays Incorrect Message 3 3
Disconnection 3 3
Failure to Cycle 3 3
False Alarm 3 3
Labelling, Instructions for Use or Training Problem 3 3
Loose or Intermittent Connection 3 3
Electrical /Electronic Property Problem 3 3
Material Erosion 2 2
Fire 2 2
Flushing Problem 2 2
Image Display Error/Artifact 2 2
Obstruction of Flow 2 2
Shipping Damage or Problem 2 2
Misconnection 2 2
Device Emits Odor 2 2
Device Contamination With Biological Material 2 2
Electrical Shorting 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Human-Device Interface Problem 2 2
Protective Measures Problem 2 2
Material Split, Cut or Torn 2 2
Failure to Eject 1 1
Unintended Electrical Shock 1 1
Data Problem 1 1
Unclear Information 1 1
Power Problem 1 1
Pressure Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
No Flow 1 1
Installation-Related Problem 1 1
Gas Leak 1 1
Environmental Compatibility Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Sensing Problem 1 1
Device Unsafe to Use in Environment 1 1
Difficult to Open or Close 1 1
Particulates 1 1
Pitted 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Failure to Reset 1 1
Inadequate Service 1 1
Smoking 1 1
Problem with Sterilization 1 1
Fitting Problem 1 1
Expiration Date Error 1 1
Contamination of Device Ingredient or Reagent 1 1
Loss of Data 1 1
Patient-Device Incompatibility 1 1
Application Program Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 297 297
No Known Impact Or Consequence To Patient 184 184
No Consequences Or Impact To Patient 161 161
Chemical Exposure 81 81
No Clinical Signs, Symptoms or Conditions 67 67
No Information 29 29
No Code Available 19 19
Headache 18 18
Death 18 18
Unspecified Infection 15 15
Exposure to Body Fluids 8 8
Complaint, Ill-Defined 8 8
Bacterial Infection 6 6
Itching Sensation 6 6
Respiratory Distress 6 6
Burning Sensation 6 6
Sneezing 6 6
Skin Discoloration 6 6
Skin Irritation 5 5
Irritation 5 5
Fungal Infection 5 5
Nausea 5 5
Dizziness 4 4
Chest Tightness/Pressure 3 3
Injury 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 3 3
Fever 3 3
Burn(s) 2 2
Inflammation 2 2
Swelling 2 2
Toxicity 2 2
Insufficient Information 2 2
Blood Loss 2 2
Electric Shock 2 2
Tingling 2 2
Vomiting 1 1
Pain 1 1
Eye Injury 1 1
Laceration(s) 1 1
Anaphylactic Shock 1 1
Asthma 1 1
Infection, Indirect 1 1
Sore Throat 1 1
Reaction 1 1
Caustic/Chemical Burns 1 1
Malaise 1 1
Pharyngitis 1 1
Chills 1 1
Abrasion 1 1
Perforation 1 1
Rash 1 1
Conjunctivitis 1 1
Dyspnea 1 1
Fungus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Jan-09-2017
2 Olympus Corporation of the Americas II Oct-19-2016
3 Steris Corporation III Nov-16-2020
-
-