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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
ELUCENT MEDICAL
  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 2
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 6
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 4379 4379

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 6796 6796
Communication or Transmission Problem 3130 3130
Peeled/Delaminated 2606 2606
Adverse Event Without Identified Device or Use Problem 2055 2058
Break 1864 1879
Poor Quality Image 1310 1310
Erratic or Intermittent Display 1243 1243
Thermal Decomposition of Device 1085 1085
Detachment of Device or Device Component 1014 1028
Failure to Clean Adequately 707 707
Fluid/Blood Leak 701 701
Degraded 498 498
Device Reprocessing Problem 487 491
Microbial Contamination of Device 456 456
Corroded 406 406
Display or Visual Feedback Problem 386 386
Material Deformation 253 253
Melted 247 247
Material Split, Cut or Torn 241 250
Loose or Intermittent Connection 222 222
Optical Obstruction 212 212
Contamination 197 197
Image Display Error/Artifact 182 182
Loss of or Failure to Bond 170 170
Obstruction of Flow 167 167
Overheating of Device 162 162
Material Fragmentation 153 156
Connection Problem 133 133
Flare or Flash 127 127
Material Separation 125 126
Gas/Air Leak 124 124
Optical Problem 123 123
Contamination /Decontamination Problem 107 107
Crack 104 108
Scratched Material 103 103
Unintended Movement 96 96
Residue After Decontamination 90 90
Electrical /Electronic Property Problem 87 87
Dent in Material 85 85
Output Problem 78 78
Leak/Splash 73 73
Mechanical Problem 70 70
Insufficient Information 67 67
Component Missing 66 66
Physical Resistance/Sticking 60 60
Material Puncture/Hole 60 60
Material Integrity Problem 58 58
Material Discolored 55 55
Difficult to Open or Close 51 51
Optical Distortion 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23195 23233
Pneumothorax 1316 1316
Hemorrhage/Bleeding 367 368
Insufficient Information 206 206
Bacterial Infection 173 173
Foreign Body In Patient 151 155
Cardiac Arrest 130 130
Unspecified Infection 116 116
Fungal Infection 92 93
Respiratory Tract Infection 72 72
Hypoxia 56 56
Stroke/CVA 55 55
Pneumonia 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 51
No Consequences Or Impact To Patient 50 50
Low Blood Pressure/ Hypotension 45 45
Respiratory Failure 44 44
Low Oxygen Saturation 42 42
Myocardial Infarction 40 40
Bradycardia 38 38
Air Embolism 30 30
Dyspnea 27 27
Hemoptysis 24 24
Chest Pain 22 22
Fever 22 22
Bronchial Hemorrhage 22 22
Arrhythmia 20 20
Convulsion/Seizure 20 20
Subclinical Infection 18 18
Airway Obstruction 17 17
Respiratory Arrest 17 17
Respiratory Insufficiency 15 15
Pleural Effusion 15 15
Viral Infection 14 14
Non specific EKG/ECG Changes 11 11
High Blood Pressure/ Hypertension 11 11
Unspecified Respiratory Problem 11 11
Pain 11 11
Device Embedded In Tissue or Plaque 9 9
Pulmonary Embolism 9 9
Drug Resistant Bacterial Infection 9 9
Ventricular Fibrillation 8 8
Chronic Obstructive Pulmonary Disease (COPD) 8 8
Ventilator Dependent 8 8
Cough 8 8
Bronchospasm 8 8
Asystole 8 8
No Patient Involvement 7 7
Cardiomyopathy 7 7
Tachycardia 7 7

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 II Mar-03-2026
22 Olympus Corporation of the Americas I Oct-16-2025
23 Olympus Corporation of the Americas I Feb-11-2025
24 Olympus Corporation of the Americas II Dec-14-2023
25 Olympus Corporation of the Americas I Nov-09-2023
26 Olympus Corporation of the Americas II Aug-31-2023
27 Olympus Corporation of the Americas II Aug-04-2023
28 Olympus Corporation of the Americas I Jul-17-2023
29 Olympus Corporation of the Americas II May-06-2022
30 Olympus Corporation of the Americas II Sep-24-2021
31 Olympus Corporation of the Americas II Sep-21-2021
32 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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