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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 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 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 2512 2512

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 6448 6448
Communication or Transmission Problem 2946 2946
Peeled/Delaminated 2550 2550
Adverse Event Without Identified Device or Use Problem 1922 1925
Break 1771 1786
Poor Quality Image 1193 1193
Erratic or Intermittent Display 1056 1056
Thermal Decomposition of Device 1046 1046
Detachment of Device or Device Component 808 822
Fluid/Blood Leak 693 693
Failure to Clean Adequately 651 651
Device Reprocessing Problem 449 453
Microbial Contamination of Device 446 446
Degraded 417 417
Display or Visual Feedback Problem 349 349
Corroded 295 295
Material Deformation 233 233
Loose or Intermittent Connection 214 214
Optical Obstruction 210 210
Melted 210 210
Material Split, Cut or Torn 188 197
Contamination 185 185
Image Display Error/Artifact 164 164
Obstruction of Flow 162 162
Overheating of Device 135 135
Loss of or Failure to Bond 133 133
Flare or Flash 117 117
Gas/Air Leak 117 117
Optical Problem 112 112
Connection Problem 106 106
Material Separation 105 106
Contamination /Decontamination Problem 98 98
Scratched Material 94 94
Unintended Movement 90 90
Residue After Decontamination 80 80
Dent in Material 76 76
Electrical /Electronic Property Problem 74 74
Output Problem 73 73
Leak/Splash 70 70
Mechanical Problem 68 68
Crack 67 71
Material Fragmentation 67 70
Insufficient Information 62 62
Component Missing 60 60
Physical Resistance/Sticking 56 56
Material Integrity Problem 55 55
Material Puncture/Hole 54 54
Difficult to Open or Close 51 51
Material Discolored 47 47
Material Twisted/Bent 43 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21497 21535
Pneumothorax 1245 1245
Hemorrhage/Bleeding 332 333
Insufficient Information 191 191
Bacterial Infection 165 165
Foreign Body In Patient 146 150
Cardiac Arrest 118 118
Unspecified Infection 102 102
Fungal Infection 92 93
Respiratory Tract Infection 69 69
Hypoxia 53 53
Stroke/CVA 52 52
Pneumonia 50 50
No Consequences Or Impact To Patient 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 48
Low Blood Pressure/ Hypotension 42 42
Respiratory Failure 40 40
Bradycardia 38 38
Myocardial Infarction 37 37
Low Oxygen Saturation 36 36
Air Embolism 26 26
Dyspnea 25 25
Hemoptysis 23 23
Fever 22 22
Chest Pain 21 21
Bronchial Hemorrhage 21 21
Convulsion/Seizure 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
Non specific EKG/ECG Changes 11 11
High Blood Pressure/ Hypertension 11 11
Unspecified Respiratory Problem 11 11
Pulmonary Embolism 9 9
Device Embedded In Tissue or Plaque 9 9
Drug Resistant Bacterial Infection 9 9
Ventricular Fibrillation 8 8
Asystole 8 8
Cough 8 8
No Patient Involvement 7 7
Cardiomyopathy 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 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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