• 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)
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 7
ANREI MEDICAL (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTS
  SUBSTANTIALLY EQUIVALENT 1
NOAH MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 8
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SERPEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 654 654
2020 515 515
2021 1357 1357
2022 2537 2537
2023 5041 5041
2024 1459 1459

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 2360 2360
Break 1886 1886
Peeled/Delaminated 1714 1714
Adverse Event Without Identified Device or Use Problem 1328 1328
Communication or Transmission Problem 1091 1091
Fluid/Blood Leak 594 594
Microbial Contamination of Device 408 408
Device Reprocessing Problem 258 258
Failure to Clean Adequately 238 238
Detachment of Device or Device Component 205 205
Poor Quality Image 199 199
Erratic or Intermittent Display 166 166
Loose or Intermittent Connection 163 163
Display or Visual Feedback Problem 135 135
Optical Obstruction 120 120
Obstruction of Flow 83 83
Contamination 74 74
Degraded 73 73
Image Display Error/Artifact 71 71
Material Split, Cut or Torn 70 70
Material Deformation 69 69
Unintended Movement 67 67
Optical Problem 65 65
Contamination /Decontamination Problem 59 59
Thermal Decomposition of Device 59 59
Insufficient Information 52 52
Leak/Splash 51 51
Electrical /Electronic Property Problem 49 49
Material Separation 47 47
Mechanical Problem 42 42
Scratched Material 40 40
Difficult to Open or Close 37 37
Component Missing 36 36
Melted 34 34
Material Twisted/Bent 33 33
Optical Distortion 32 32
Corroded 31 31
Material Fragmentation 30 30
Defective Device 30 30
Physical Resistance/Sticking 29 29
Failure to Power Up 27 27
Output Problem 26 26
Device Contamination with Chemical or Other Material 26 26
Difficult to Remove 24 24
Fracture 24 24
Defective Component 21 21
Material Integrity Problem 20 20
Entrapment of Device 20 20
Appropriate Term/Code Not Available 20 20
Overheating of Device 18 18
Use of Device Problem 15 15
Retraction Problem 14 14
Device Damaged by Another Device 12 12
Improper or Incorrect Procedure or Method 11 11
Material Puncture/Hole 11 11
Device Fell 11 11
No Visual Prompts/Feedback 11 11
Partial Blockage 10 10
Dent in Material 10 10
Failure to Disconnect 10 10
Deformation Due to Compressive Stress 10 10
Mechanical Jam 10 10
Gas/Air Leak 9 9
Connection Problem 9 9
Residue After Decontamination 9 9
Disconnection 9 9
Crack 8 8
No Device Output 8 8
Energy Output Problem 7 7
Signal Artifact/Noise 7 7
Collapse 7 7
Difficult to Advance 7 7
Excessive Heating 7 7
Unexpected Shutdown 6 6
Device Handling Problem 6 6
Device-Device Incompatibility 6 6
Suction Problem 6 6
Stretched 5 5
Failure to Advance 5 5
Activation, Positioning or Separation Problem 5 5
Device Dislodged or Dislocated 5 5
Naturally Worn 5 5
Power Problem 5 5
Component Incompatible 5 5
Flaked 5 5
Moisture Damage 5 5
Failure to Eject 5 5
Noise, Audible 4 4
Unintended Application Program Shut Down 4 4
Suction Failure 4 4
Fire 4 4
Material Disintegration 4 4
Biofilm coating in Device 4 4
Intermittent Continuity 4 4
Overcorrection 4 4
Electrical Shorting 4 4
Structural Problem 4 4
Visual Prompts will not Clear 4 4
Device Damaged Prior to Use 3 3
Material Rupture 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8875 8875
Pneumothorax 751 751
No Consequences Or Impact To Patient 630 630
Unspecified Infection 232 232
Hemorrhage/Bleeding 206 206
Bacterial Infection 174 174
No Known Impact Or Consequence To Patient 127 127
Insufficient Information 95 95
Foreign Body In Patient 84 84
Fungal Infection 81 81
No Patient Involvement 70 70
Pneumonia 61 61
Cardiac Arrest 59 59
Respiratory Tract Infection 50 50
Hypoxia 41 41
Respiratory Failure 26 26
Low Oxygen Saturation 25 25
Low Blood Pressure/ Hypotension 23 23
Bradycardia 22 22
Myocardial Infarction 22 22
Viral Infection 22 22
Dyspnea 21 21
Fever 21 21
Injury 20 20
Stroke/CVA 18 18
Chest Pain 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Device Embedded In Tissue or Plaque 15 15
Death 15 15
Hemoptysis 14 14
Air Embolism 13 13
Airway Obstruction 11 11
Arrhythmia 10 10
No Information 10 10
Unspecified Respiratory Problem 10 10
Convulsion/Seizure 9 9
Blood Loss 9 9
High Blood Pressure/ Hypertension 9 9
Inflammation 8 8
Pain 8 8
Respiratory Arrest 8 8
Non specific EKG/ECG Changes 7 7
Respiratory Insufficiency 6 6
Bronchial Hemorrhage 6 6
Cough 5 5
No Code Available 5 5
Asystole 5 5
Bronchospasm 5 5
Unspecified Tissue Injury 5 5
Hypersensitivity/Allergic reaction 5 5
Perforation 5 5
Pleural Effusion 5 5
Sore Throat 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Ventricular Fibrillation 4 4
Ventilator Dependent 4 4
Fibrosis 4 4
Patient Problem/Medical Problem 3 3
Unintended Extubation 3 3
Unintended Radiation Exposure 3 3
Hematemesis 3 3
Vomiting 3 3
Oversedation 3 3
Shock 3 3
Laceration(s) 3 3
Hematoma 3 3
Aspiration/Inhalation 3 3
Abdominal Pain 3 3
Abscess 3 3
Asthma 2 2
Atrial Fibrillation 2 2
Cardiomyopathy 2 2
Burn(s) 2 2
Abnormal Blood Gases 2 2
Headache 2 2
Hypovolemic Shock 2 2
Hemothorax 2 2
Suffocation 2 2
Tachycardia 2 2
Tissue Damage 2 2
Transient Ischemic Attack 2 2
Sepsis 2 2
Septic Shock 2 2
Brain Injury 2 2
Coma 2 2
Pancreatitis 2 2
Genital Bleeding 2 2
Gastrointestinal Hemorrhage 2 2
Decreased Appetite 2 2
Drug Resistant Bacterial Infection 2 2
Decreased Respiratory Rate 2 2
Obstruction/Occlusion 2 2
Syncope/Fainting 2 2
Heart Block 2 2
Pleural Empyema 2 2
Unspecified Heart Problem 2 2
Aspiration Pneumonitis 1 1
Cardiovascular Insufficiency 1 1
Cancer 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Dec-01-2023
2 AURIS HEALTH INC II Nov-16-2019
3 Aizu Olympus Co., Ltd. II Nov-17-2023
4 Aizu Olympus Co., Ltd. III Nov-17-2023
5 Aizu Olympus Co., Ltd. II Aug-19-2022
6 Ambu Inc. II Jan-11-2024
7 Aomori Olympus Co., Ltd. II Feb-05-2021
8 Intuitive Surgical, Inc. II Oct-15-2021
9 Intuitive Surgical, Inc. II Nov-25-2020
10 Intuitive Surgical, Inc. II Sep-10-2020
11 Karl Storz Endoscopy II Apr-03-2024
12 Karl Storz Endoscopy II Sep-15-2023
13 Karl Storz Endoscopy II May-10-2022
14 Karl Storz Endoscopy II Aug-31-2019
15 Lymol Medical Corporation II Sep-24-2021
16 Olympus Corporation of the Americas II Dec-14-2023
17 Olympus Corporation of the Americas I Nov-09-2023
18 Olympus Corporation of the Americas II Aug-31-2023
19 Olympus Corporation of the Americas II Aug-04-2023
20 Olympus Corporation of the Americas I Jul-17-2023
21 Olympus Corporation of the Americas II May-06-2022
22 Olympus Corporation of the Americas II Sep-24-2021
23 Olympus Corporation of the Americas II Sep-21-2021
24 Olympus Corporation of the Americas II Sep-25-2020
25 Olympus Corporation of the Americas II Aug-02-2019
26 Prodimed Plastimed Division II Jul-04-2020
27 Shirakawa Olympus Co., Ltd. II Jan-09-2024
-
-