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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)
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 7
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BRONCUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONTRA HEALTHCARE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HIMAGING TECHNOLOGY (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  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
NOVATECH SA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
OTU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SERPEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SANPING IMAGE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG UE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1358 1360
2022 2541 2548
2023 5064 5089
2024 6051 6064
2025 6619 6619
2026 812 812

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 6098 6098
Communication or Transmission Problem 2765 2765
Peeled/Delaminated 2456 2456
Adverse Event Without Identified Device or Use Problem 1827 1830
Break 1709 1724
Poor Quality Image 1050 1050
Thermal Decomposition of Device 991 991
Erratic or Intermittent Display 874 874
Fluid/Blood Leak 689 689
Detachment of Device or Device Component 668 682
Failure to Clean Adequately 599 599
Microbial Contamination of Device 436 436
Device Reprocessing Problem 412 416
Degraded 340 340
Display or Visual Feedback Problem 316 316
Optical Obstruction 208 208
Loose or Intermittent Connection 206 206
Material Deformation 206 206
Corroded 186 186
Material Split, Cut or Torn 172 181
Obstruction of Flow 158 158
Image Display Error/Artifact 156 156
Contamination 152 152
Melted 127 127
Loss of or Failure to Bond 108 108
Optical Problem 106 106
Gas/Air Leak 104 104
Overheating of Device 101 101
Flare or Flash 94 94
Unintended Movement 89 89
Connection Problem 89 89
Contamination /Decontamination Problem 87 87
Scratched Material 87 87
Material Separation 87 88
Electrical /Electronic Property Problem 73 73
Dent in Material 71 71
Output Problem 71 71
Leak/Splash 69 69
Mechanical Problem 64 64
Residue After Decontamination 63 63
Insufficient Information 61 61
Material Fragmentation 56 59
Physical Resistance/Sticking 55 55
Component Missing 54 54
Difficult to Open or Close 51 51
Material Puncture/Hole 50 50
Crack 49 53
Material Integrity Problem 49 49
Material Twisted/Bent 43 44
Optical Distortion 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19905 19943
Pneumothorax 1172 1172
Hemorrhage/Bleeding 315 316
Insufficient Information 183 183
Bacterial Infection 165 165
Foreign Body In Patient 144 148
Cardiac Arrest 109 109
Unspecified Infection 100 100
Fungal Infection 90 91
Respiratory Tract Infection 68 68
Hypoxia 51 51
Pneumonia 50 50
Stroke/CVA 50 50
No Consequences Or Impact To Patient 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 47
Low Blood Pressure/ Hypotension 41 41
Respiratory Failure 40 40
Bradycardia 38 38
Myocardial Infarction 37 37
Low Oxygen Saturation 36 36
Air Embolism 26 26
Dyspnea 25 25
Fever 22 22
Hemoptysis 22 22
Chest Pain 21 21
Convulsion/Seizure 20 20
Bronchial Hemorrhage 20 20
Subclinical Infection 18 18
Arrhythmia 17 17
Respiratory Arrest 16 16
Airway Obstruction 15 15
Pleural Effusion 15 15
Viral Infection 14 14
Respiratory Insufficiency 13 13
Pain 11 11
High Blood Pressure/ Hypertension 11 11
Non specific EKG/ECG Changes 11 11
Unspecified Respiratory Problem 11 11
Device Embedded In Tissue or Plaque 9 9
Drug Resistant Bacterial Infection 9 9
Pulmonary Embolism 9 9
Asystole 8 8
Cough 8 8
Ventricular Fibrillation 7 7
Cardiomyopathy 7 7
No Patient Involvement 7 7
Bronchospasm 7 7
Unspecified Tissue Injury 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7
Burn(s) 6 6

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. II Aug-19-2022
5 Ambu Inc. II May-06-2025
6 Ambu Inc. II Jan-11-2024
7 Aomori Olympus Co., Ltd. II Feb-05-2021
8 Auris Health, Inc II Feb-17-2026
9 Intuitive Surgical, Inc. II Jan-21-2026
10 Intuitive Surgical, Inc. II Aug-23-2024
11 Intuitive Surgical, Inc. II Oct-15-2021
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 Noah Medical Corporation II Nov-26-2025
21 Olympus Corporation of the Americas I Oct-16-2025
22 Olympus Corporation of the Americas I Feb-11-2025
23 Olympus Corporation of the Americas II Dec-14-2023
24 Olympus Corporation of the Americas I Nov-09-2023
25 Olympus Corporation of the Americas II Aug-31-2023
26 Olympus Corporation of the Americas II Aug-04-2023
27 Olympus Corporation of the Americas I Jul-17-2023
28 Olympus Corporation of the Americas II May-06-2022
29 Olympus Corporation of the Americas II Sep-24-2021
30 Olympus Corporation of the Americas II Sep-21-2021
31 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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