• 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 bronchoscope (flexible or rigid)
Regulation Description Bronchoscope (flexible or rigid) and accessories.
Definition A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 CodeEOQ
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 3
ANREI MEDICAL (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AURIS SURGICAL ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
BODY VISION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 8
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 4
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 297 297
2017 336 336
2018 279 279
2019 654 654
2020 515 515
2021 1028 1028

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1067 1067
Adverse Event Without Identified Device or Use Problem 572 572
Microbial Contamination of Device 365 365
Appropriate Term/Code Not Available 139 139
Bent 80 80
Device Reprocessing Problem 79 79
Loose or Intermittent Connection 67 67
Detachment of Device or Device Component 63 63
Fluid Leak 53 53
No Display/Image 51 51
Device Issue 49 49
Insufficient Information 48 48
Contamination /Decontamination Problem 44 44
Peeled/Delaminated 40 40
Nonstandard Device 25 25
Electrical /Electronic Property Problem 25 25
Detachment Of Device Component 25 25
Material Puncture/Hole 22 22
Material Deformation 22 22
Material Split, Cut or Torn 21 21
Leak/Splash 21 21
Fracture 21 21
Material Fragmentation 20 20
Material Separation 20 20
Contamination 19 19
Display or Visual Feedback Problem 18 18
Material Twisted/Bent 18 18
Poor Quality Image 16 16
Difficult to Remove 16 16
Entrapment of Device 15 15
Difficult to Open or Close 15 15
Defective Device 15 15
Physical Resistance/Sticking 14 14
Failure to Power Up 13 13
Component Missing 12 12
Device Contamination with Chemical or Other Material 12 12
Mechanical Problem 11 11
Device Fell 10 10
Failure to Clean Adequately 10 10
Unintended Movement 8 8
Device Operates Differently Than Expected 8 8
Use of Device Problem 8 8
Image Display Error/Artifact 7 7
Erratic or Intermittent Display 7 7
Failure to Disconnect 7 7
Device Contamination With Biological Material 6 6
Device Disinfection Or Sterilization Issue 6 6
Device Damaged by Another Device 6 6
Material Integrity Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Suction Problem 5 5
Retraction Problem 5 5
Energy Output Problem 5 5
Difficult to Advance 5 5
Gas Leak 5 5
Defective Component 5 5
Failure to Advance 5 5
Obstruction of Flow 4 4
Device Dislodged or Dislocated 4 4
Residue After Decontamination 4 4
Communication or Transmission Problem 4 4
Connection Problem 4 4
Device Handling Problem 4 4
Output Problem 4 4
Crack 4 4
Biofilm coating in Device 4 4
Loss of or Failure to Bond 3 3
Thermal Decomposition of Device 3 3
Corroded 3 3
Component Incompatible 3 3
Difficult to Insert 3 3
Overheating of Device 3 3
Failure to Sense 3 3
Material Perforation 3 3
Positioning Problem 3 3
Mechanical Jam 3 3
Dent in Material 3 3
Structural Problem 3 3
Device Inoperable 2 2
Activation, Positioning or SeparationProblem 2 2
Material Protrusion/Extrusion 2 2
Optical Problem 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Suction Failure 2 2
Separation Problem 2 2
Device Damaged Prior to Use 2 2
Fitting Problem 2 2
Material Rupture 2 2
Inadequate Service 2 2
Device Slipped 2 2
Smoking 2 2
Sticking 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Material Disintegration 2 2
Inflation Problem 2 2
Unintended Ejection 2 2
Flaked 2 2
Failure to Fold 1 1
Image Resolution Poor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 832 832
No Clinical Signs, Symptoms or Conditions 717 717
Unspecified Infection 421 421
No Known Impact Or Consequence To Patient 326 326
Bacterial Infection 227 227
Pneumothorax 125 125
No Patient Involvement 80 80
Fungal Infection 67 67
Pneumonia 37 37
Insufficient Information 37 37
Foreign Body In Patient 35 35
Respiratory Tract Infection 32 32
Device Embedded In Tissue or Plaque 31 31
Hemorrhage/Bleeding 31 31
Injury 29 29
Death 28 28
No Code Available 23 23
No Information 22 22
Blood Loss 19 19
Hypoxia 13 13
Inflammation 8 8
Viral Infection 8 8
Cardiac Arrest 7 7
Patient Problem/Medical Problem 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Low Oxygen Saturation 5 5
Fever 5 5
Myocardial Infarction 4 4
Pain 4 4
Dyspnea 4 4
Perforation 4 4
Abscess 3 3
Bronchial Hemorrhage 3 3
Cough 3 3
Cancer 2 2
Abnormal Blood Gases 2 2
Pulmonary Embolism 2 2
Burn(s) 2 2
Chest Pain 2 2
Hematoma 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Suffocation 2 2
Tissue Damage 2 2
Coma 2 2
Burn, Thermal 2 2
Electric Shock 1 1
Chemical Exposure 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Skin Tears 1 1
Pseudoaneurysm 1 1
Intraoperative Pain 1 1
Superficial (First Degree) Burn 1 1
Vomiting 1 1
Chills 1 1
Pleural Effusion 1 1
Stenosis 1 1
Anxiety 1 1
Discomfort 1 1
Impaired Healing 1 1
Sore Throat 1 1
Extubate 1 1
Hemoptysis 1 1
Foreign Body Reaction 1 1
Paralysis 1 1
Laceration(s) 1 1
Pulmonary Infarction 1 1
Respiratory Distress 1 1
Seizures 1 1
Shock 1 1
Abdominal Pain 1 1
Abrasion 1 1
Airway Obstruction 1 1
Arrhythmia 1 1
Aspiration/Inhalation 1 1
Edema 1 1
Eye Injury 1 1
Fatigue 1 1
Cardiopulmonary Arrest 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Unspecified Blood or Lymphatic problem 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Nov-16-2019
2 Aomori Olympus Co., Ltd. II Feb-05-2021
3 Intuitive Surgical, Inc. II Oct-15-2021
4 Intuitive Surgical, Inc. II Nov-25-2020
5 Intuitive Surgical, Inc. II Sep-10-2020
6 Karl Storz Endoscopy II Aug-31-2019
7 Lymol Medical Corporation II Sep-24-2021
8 Olympus Corporation of the Americas II Sep-24-2021
9 Olympus Corporation of the Americas II Sep-21-2021
10 Olympus Corporation of the Americas II Sep-25-2020
11 Olympus Corporation of the Americas II Aug-02-2019
12 Olympus Corporation of the Americas II Sep-29-2018
13 Pentax Medical Company II Jun-28-2016
14 Pentax of America Inc II Jun-09-2017
15 Pentax of America Inc II Dec-14-2016
16 Pentax of America Inc II Sep-22-2016
17 Prodimed Plastimed Division II Jul-04-2020
-
-