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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 3
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
BRONCUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
HUNAN VATHIN MEDICAL INSTRUMENT CO.LTD
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION, INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTS
  SUBSTANTIALLY EQUIVALENT 1
NOAH MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 7
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 3

MDR Year MDR Reports MDR Events
2020 515 515
2021 1357 1357
2022 2541 2541
2023 5065 5065
2024 6051 6051

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3825 3825
Peeled/Delaminated 2177 2177
Communication or Transmission Problem 1720 1720
Break 1670 1670
Adverse Event Without Identified Device or Use Problem 1517 1517
Thermal Decomposition of Device 769 769
Fluid/Blood Leak 666 666
Microbial Contamination of Device 408 408
Failure to Clean Adequately 380 380
Poor Quality Image 346 346
Device Reprocessing Problem 291 291
Detachment of Device or Device Component 283 283
Erratic or Intermittent Display 241 241
Optical Obstruction 182 182
Loose or Intermittent Connection 180 180
Display or Visual Feedback Problem 158 158
Obstruction of Flow 111 111
Contamination 104 104
Material Split, Cut or Torn 92 92
Degraded 91 91
Image Display Error/Artifact 89 89
Melted 80 80
Unintended Movement 77 77
Material Deformation 77 77
Optical Problem 71 71
Leak/Splash 60 60
Insufficient Information 59 59
Contamination /Decontamination Problem 57 57
Electrical /Electronic Property Problem 57 57
Output Problem 54 54
Mechanical Problem 51 51
Material Separation 51 51
Scratched Material 50 50
Difficult to Open or Close 45 45
Component Missing 43 43
Corroded 42 42
Physical Resistance/Sticking 36 36
Optical Distortion 35 35
Material Twisted/Bent 33 33
Defective Device 32 32
Material Fragmentation 32 32
Failure to Power Up 30 30
Device Contamination with Chemical or Other Material 28 28
Delivered as Unsterile Product 25 25
Overheating of Device 25 25
Material Integrity Problem 25 25
Appropriate Term/Code Not Available 24 24
Difficult to Remove 23 23
Manufacturing, Packaging or Shipping Problem 22 22
No Visual Prompts/Feedback 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13069 13069
Pneumothorax 949 949
No Consequences Or Impact To Patient 274 274
Hemorrhage/Bleeding 264 264
Bacterial Infection 164 164
Unspecified Infection 158 158
Insufficient Information 106 106
Foreign Body In Patient 100 100
Fungal Infection 88 88
Cardiac Arrest 80 80
No Patient Involvement 67 67
Pneumonia 61 61
Respiratory Tract Infection 61 61
Hypoxia 48 48
No Known Impact Or Consequence To Patient 46 46
Stroke/CVA 36 36
Respiratory Failure 35 35
Bradycardia 34 34
Low Blood Pressure/ Hypotension 32 32
Low Oxygen Saturation 28 28
Myocardial Infarction 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Viral Infection 22 22
Air Embolism 21 21
Fever 21 21
Dyspnea 21 21
Hemoptysis 19 19
Chest Pain 17 17
Convulsion/Seizure 16 16
Arrhythmia 15 15
Airway Obstruction 14 14
Respiratory Arrest 12 12
Device Embedded In Tissue or Plaque 11 11
Pleural Effusion 11 11
High Blood Pressure/ Hypertension 10 10
Unspecified Respiratory Problem 10 10
Pain 9 9
Respiratory Insufficiency 9 9
Non specific EKG/ECG Changes 9 9
Bronchial Hemorrhage 8 8
Drug Resistant Bacterial Infection 8 8
Cardiomyopathy 7 7
Asystole 7 7
Cough 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7
No Information 7 7
Perforation 6 6
Bronchospasm 6 6
Ventilator Dependent 5 5
Sore Throat 5 5

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