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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 10
ANREI MEDICAL (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AURIS SURGICAL ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
BODY VISION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BRONCUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
BRONCUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRONCUS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL
  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
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTS
  SUBSTANTIALLY EQUIVALENT 1
NOAH MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 10
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 2
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 9
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
SANOVAS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 5
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 98 98
2015 132 132
2016 297 297
2017 336 336
2018 279 279
2019 654 654
2020 515 515
2021 1357 1357
2022 2541 2541
2023 5065 5065
2024 3898 3898

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3275 3275
Break 2095 2095
Peeled/Delaminated 2050 2050
Adverse Event Without Identified Device or Use Problem 1707 1707
Communication or Transmission Problem 1458 1458
Fluid/Blood Leak 650 650
Microbial Contamination of Device 647 647
Failure to Clean Adequately 334 334
Device Reprocessing Problem 311 311
Poor Quality Image 292 292
Detachment of Device or Device Component 279 279
Loose or Intermittent Connection 213 213
Erratic or Intermittent Display 206 206
Optical Obstruction 155 155
Appropriate Term/Code Not Available 151 151
Display or Visual Feedback Problem 139 139
Thermal Decomposition of Device 134 134
Contamination 115 115
Obstruction of Flow 105 105
Insufficient Information 99 99
Material Split, Cut or Torn 96 96
Bent 92 92
Degraded 88 88
Contamination /Decontamination Problem 83 83
Image Display Error/Artifact 82 82
Material Deformation 81 81
Unintended Movement 73 73
Melted 68 68
Optical Problem 68 68
Material Separation 61 61
Leak/Splash 60 60
Mechanical Problem 52 52
Electrical /Electronic Property Problem 50 50
Difficult to Open or Close 49 49
Device Issue 49 49
Scratched Material 48 48
Component Missing 46 46
Material Fragmentation 45 45
Output Problem 41 41
Corroded 39 39
Detachment Of Device Component 37 37
Difficult to Remove 36 36
Optical Distortion 35 35
Material Twisted/Bent 34 34
Physical Resistance/Sticking 34 34
Fracture 33 33
Defective Device 33 33
Device Contamination with Chemical or Other Material 33 33
Material Puncture/Hole 32 32
Failure to Power Up 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11099 11099
No Consequences Or Impact To Patient 887 887
Pneumothorax 886 886
Unspecified Infection 515 515
Bacterial Infection 412 412
No Known Impact Or Consequence To Patient 347 347
Hemorrhage/Bleeding 243 243
Fungal Infection 119 119
Foreign Body In Patient 110 110
Insufficient Information 98 98
No Patient Involvement 81 81
Cardiac Arrest 68 68
Pneumonia 66 66
Respiratory Tract Infection 58 58
Device Embedded In Tissue or Plaque 48 48
Hypoxia 47 47
Death 33 33
No Information 32 32
Injury 30 30
Stroke/CVA 28 28
Low Blood Pressure/ Hypotension 28 28
Respiratory Failure 28 28
Myocardial Infarction 28 28
No Code Available 27 27
Low Oxygen Saturation 27 27
Dyspnea 24 24
Bradycardia 24 24
Viral Infection 22 22
Fever 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Blood Loss 20 20
Air Embolism 19 19
Chest Pain 18 18
Hemoptysis 18 18
Airway Obstruction 14 14
Arrhythmia 12 12
Respiratory Arrest 10 10
Unspecified Respiratory Problem 10 10
Convulsion/Seizure 10 10
Pain 10 10
High Blood Pressure/ Hypertension 10 10
Perforation 9 9
Inflammation 9 9
Pleural Effusion 8 8
Drug Resistant Bacterial Infection 8 8
Respiratory Insufficiency 7 7
Bronchial Hemorrhage 7 7
Non specific EKG/ECG Changes 7 7
Burn(s) 7 7
Cough 7 7

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Dec-01-2023
2 AURIS HEALTH INC II Nov-16-2019
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 ConMed Corporation II Dec-10-2012
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 Karl Storz Endoscopy II Aug-31-2019
17 Lymol Medical Corporation II Sep-24-2021
18 Noah Medical II May-01-2024
19 Olympus Corporation of the Americas II Dec-14-2023
20 Olympus Corporation of the Americas I Nov-09-2023
21 Olympus Corporation of the Americas II Aug-31-2023
22 Olympus Corporation of the Americas II Aug-04-2023
23 Olympus Corporation of the Americas I Jul-17-2023
24 Olympus Corporation of the Americas II May-06-2022
25 Olympus Corporation of the Americas II Sep-24-2021
26 Olympus Corporation of the Americas II Sep-21-2021
27 Olympus Corporation of the Americas II Sep-25-2020
28 Olympus Corporation of the Americas II Aug-02-2019
29 Olympus Corporation of the Americas II Sep-29-2018
30 Pentax Medical Company II Jun-28-2016
31 Pentax Medical Company II Jan-20-2012
32 Pentax of America Inc II Jun-09-2017
33 Pentax of America Inc II Dec-14-2016
34 Pentax of America Inc II Sep-22-2016
35 Prodimed Plastimed Division II Jul-04-2020
36 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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