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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 3
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
BRONCUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTRA HEALTHCARE SOLUTIONS, LLC
  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 2
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
NOVATECH SA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 7
  1.  K192164  Single Use Guide Sheath Kit K-401, K-402, & Single ...
  2.  K200342  Single Use Grasping Forceps FG-214P, Single Use Gr ...
  3.  K200397  Single Use Biopsy Forceps FB-456D
  4.  K201300  Airway Mobilescope
  5.  K201758  EVIS EXERA III Bronchovideoscope Olympus BF-XP190, ...
  6.  K212667  Single Use Guide Sheath Kit-401, K-402
  7.  K221631  Tracheal Intubation Fiberscope OLYMPUS LF-P, VISER ...
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
SCIVITA MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SHENZHEN SANPING IMAGE TECHNOLOGY 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
2025 1516 1516

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4357 4357
Peeled/Delaminated 2209 2209
Communication or Transmission Problem 2011 2011
Break 1730 1730
Adverse Event Without Identified Device or Use Problem 1611 1611
Thermal Decomposition of Device 811 811
Fluid/Blood Leak 686 686
Microbial Contamination of Device 431 431
Failure to Clean Adequately 419 419
Poor Quality Image 403 403
Device Reprocessing Problem 334 334
Detachment of Device or Device Component 334 334
Erratic or Intermittent Display 292 292
Optical Obstruction 200 200
Loose or Intermittent Connection 189 189
Display or Visual Feedback Problem 177 177
Obstruction of Flow 127 127
Degraded 125 125
Material Split, Cut or Torn 116 116
Contamination 109 109
Material Deformation 105 105
Image Display Error/Artifact 98 98
Melted 92 92
Unintended Movement 81 81
Optical Problem 78 78
Leak/Splash 67 67
Insufficient Information 60 60
Contamination /Decontamination Problem 59 59
Electrical /Electronic Property Problem 59 59
Material Separation 57 57
Output Problem 56 56
Mechanical Problem 55 55
Scratched Material 54 54
Corroded 51 51
Difficult to Open or Close 45 45
Component Missing 45 45
Material Fragmentation 41 41
Physical Resistance/Sticking 40 40
Optical Distortion 36 36
Material Twisted/Bent 35 35
Defective Device 32 32
Failure to Power Up 31 31
Material Integrity Problem 29 29
Material Puncture/Hole 29 29
Device Contamination with Chemical or Other Material 28 28
Overheating of Device 28 28
Delivered as Unsterile Product 25 25
Appropriate Term/Code Not Available 24 24
Connection Problem 23 23
Difficult to Remove 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14449 14449
Pneumothorax 1007 1007
Hemorrhage/Bleeding 277 277
No Consequences Or Impact To Patient 274 274
Bacterial Infection 173 173
Unspecified Infection 159 159
Insufficient Information 123 123
Foreign Body In Patient 121 121
Fungal Infection 89 89
Cardiac Arrest 85 85
No Patient Involvement 67 67
Pneumonia 62 62
Respiratory Tract Infection 61 61
Hypoxia 48 48
No Known Impact Or Consequence To Patient 46 46
Stroke/CVA 39 39
Respiratory Failure 36 36
Bradycardia 34 34
Low Blood Pressure/ Hypotension 32 32
Myocardial Infarction 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Low Oxygen Saturation 28 28
Viral Infection 22 22
Dyspnea 22 22
Air Embolism 21 21
Fever 21 21
Hemoptysis 19 19
Chest Pain 17 17
Airway Obstruction 16 16
Arrhythmia 16 16
Convulsion/Seizure 16 16
Device Embedded In Tissue or Plaque 15 15
Respiratory Arrest 13 13
Pleural Effusion 11 11
High Blood Pressure/ Hypertension 11 11
Respiratory Insufficiency 10 10
Unspecified Respiratory Problem 10 10
Pain 9 9
Bronchial Hemorrhage 9 9
Non specific EKG/ECG Changes 9 9
Drug Resistant Bacterial Infection 8 8
Cardiomyopathy 7 7
Asystole 7 7
No Information 7 7
Cough 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7
Bronchospasm 6 6
Unspecified Tissue Injury 6 6
Ventilator Dependent 6 6
Perforation 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. III Nov-17-2023
5 Aizu Olympus Co., Ltd. II Aug-19-2022
6 Ambu Inc. II May-06-2025
7 Ambu Inc. II Jan-11-2024
8 Aomori Olympus Co., Ltd. II Feb-05-2021
9 Intuitive Surgical, Inc. II Aug-23-2024
10 Intuitive Surgical, Inc. II Oct-15-2021
11 Intuitive Surgical, Inc. II Nov-25-2020
12 Intuitive Surgical, Inc. II Sep-10-2020
13 Karl Storz Endoscopy II Apr-03-2024
14 Karl Storz Endoscopy II Sep-15-2023
15 Karl Storz Endoscopy II May-10-2022
16 Lymol Medical Corporation II Sep-24-2021
17 Noah Medical II Dec-20-2024
18 Noah Medical II Dec-18-2024
19 Noah Medical II Dec-13-2024
20 Noah Medical II May-01-2024
21 Olympus Corporation of the Americas I Feb-11-2025
22 Olympus Corporation of the Americas II Dec-14-2023
23 Olympus Corporation of the Americas I Nov-09-2023
24 Olympus Corporation of the Americas II Aug-31-2023
25 Olympus Corporation of the Americas II Aug-04-2023
26 Olympus Corporation of the Americas I Jul-17-2023
27 Olympus Corporation of the Americas II May-06-2022
28 Olympus Corporation of the Americas II Sep-24-2021
29 Olympus Corporation of the Americas II Sep-21-2021
30 Olympus Corporation of the Americas II Sep-25-2020
31 Prodimed Plastimed Division II Jul-04-2020
32 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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