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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 7
ANREI MEDICAL (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
BRONCUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 8
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 7
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
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
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 3272 3272
Peeled/Delaminated 2041 2041
Break 1963 1963
Adverse Event Without Identified Device or Use Problem 1508 1508
Communication or Transmission Problem 1458 1458
Fluid/Blood Leak 650 650
Microbial Contamination of Device 448 448
Failure to Clean Adequately 334 334
Poor Quality Image 289 289
Device Reprocessing Problem 274 274
Detachment of Device or Device Component 267 267
Erratic or Intermittent Display 206 206
Loose or Intermittent Connection 180 180
Optical Obstruction 155 155
Display or Visual Feedback Problem 139 139
Thermal Decomposition of Device 130 130
Obstruction of Flow 101 101
Contamination 96 96
Material Split, Cut or Torn 89 89
Degraded 88 88
Image Display Error/Artifact 81 81
Material Deformation 74 74
Insufficient Information 72 72
Unintended Movement 72 72
Melted 68 68
Optical Problem 68 68
Contamination /Decontamination Problem 60 60
Leak/Splash 57 57
Material Separation 50 50
Electrical /Electronic Property Problem 50 50
Mechanical Problem 49 49
Difficult to Open or Close 49 49
Scratched Material 48 48
Component Missing 42 42
Output Problem 41 41
Corroded 39 39
Optical Distortion 35 35
Material Fragmentation 35 35
Material Twisted/Bent 34 34
Physical Resistance/Sticking 32 32
Defective Device 32 32
Failure to Power Up 29 29
Device Contamination with Chemical or Other Material 28 28
Difficult to Remove 26 26
Material Integrity Problem 26 26
Fracture 25 25
Overheating of Device 22 22
Defective Component 22 22
Appropriate Term/Code Not Available 20 20
Entrapment of Device 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11099 11099
Pneumothorax 878 878
No Consequences Or Impact To Patient 630 630
Unspecified Infection 238 238
Hemorrhage/Bleeding 231 231
Bacterial Infection 197 197
No Known Impact Or Consequence To Patient 127 127
Insufficient Information 98 98
Foreign Body In Patient 95 95
Fungal Infection 91 91
No Patient Involvement 70 70
Cardiac Arrest 68 68
Pneumonia 62 62
Respiratory Tract Infection 58 58
Hypoxia 45 45
Low Blood Pressure/ Hypotension 28 28
Stroke/CVA 28 28
Respiratory Failure 28 28
Myocardial Infarction 28 28
Low Oxygen Saturation 27 27
Bradycardia 24 24
Dyspnea 23 23
Viral Infection 22 22
Fever 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Injury 20 20
Air Embolism 19 19
Chest Pain 18 18
Hemoptysis 18 18
Death 15 15
Device Embedded In Tissue or Plaque 15 15
Airway Obstruction 14 14
Arrhythmia 12 12
Respiratory Arrest 10 10
High Blood Pressure/ Hypertension 10 10
Unspecified Respiratory Problem 10 10
Convulsion/Seizure 10 10
No Information 10 10
Blood Loss 9 9
Pleural Effusion 8 8
Pain 8 8
Inflammation 8 8
Drug Resistant Bacterial Infection 8 8
Cough 7 7
Chronic Obstructive Pulmonary Disease (COPD) 7 7
Bronchial Hemorrhage 7 7
Respiratory Insufficiency 7 7
Non specific EKG/ECG Changes 7 7
Bronchospasm 6 6
Perforation 6 6

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 Intuitive Surgical, Inc. II Aug-23-2024
9 Intuitive Surgical, Inc. II Oct-15-2021
10 Intuitive Surgical, Inc. II Nov-25-2020
11 Intuitive Surgical, Inc. II Sep-10-2020
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 Karl Storz Endoscopy II Aug-31-2019
16 Lymol Medical Corporation II Sep-24-2021
17 Noah Medical II May-01-2024
18 Olympus Corporation of the Americas II Dec-14-2023
19 Olympus Corporation of the Americas I Nov-09-2023
20 Olympus Corporation of the Americas II Aug-31-2023
21 Olympus Corporation of the Americas II Aug-04-2023
22 Olympus Corporation of the Americas I Jul-17-2023
23 Olympus Corporation of the Americas II May-06-2022
24 Olympus Corporation of the Americas II Sep-24-2021
25 Olympus Corporation of the Americas II Sep-21-2021
26 Olympus Corporation of the Americas II Sep-25-2020
27 Olympus Corporation of the Americas II Aug-02-2019
28 Prodimed Plastimed Division II Jul-04-2020
29 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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