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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
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
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 1083 1083

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4210 4210
Peeled/Delaminated 2192 2192
Communication or Transmission Problem 1943 1943
Break 1722 1722
Adverse Event Without Identified Device or Use Problem 1582 1582
Thermal Decomposition of Device 795 795
Fluid/Blood Leak 683 683
Microbial Contamination of Device 424 424
Failure to Clean Adequately 409 409
Poor Quality Image 380 380
Detachment of Device or Device Component 322 322
Device Reprocessing Problem 318 318
Erratic or Intermittent Display 273 273
Optical Obstruction 198 198
Loose or Intermittent Connection 188 188
Display or Visual Feedback Problem 167 167
Obstruction of Flow 124 124
Degraded 110 110
Material Split, Cut or Torn 108 108
Contamination 107 107
Image Display Error/Artifact 95 95
Material Deformation 91 91
Melted 91 91
Unintended Movement 80 80
Optical Problem 78 78
Leak/Splash 67 67
Insufficient Information 60 60
Contamination /Decontamination Problem 58 58
Electrical /Electronic Property Problem 57 57
Material Separation 56 56
Output Problem 55 55
Mechanical Problem 54 54
Scratched Material 52 52
Corroded 46 46
Difficult to Open or Close 45 45
Component Missing 44 44
Material Fragmentation 40 40
Physical Resistance/Sticking 38 38
Optical Distortion 36 36
Material Twisted/Bent 34 34
Defective Device 32 32
Failure to Power Up 30 30
Device Contamination with Chemical or Other Material 28 28
Overheating of Device 28 28
Material Integrity Problem 27 27
Material Puncture/Hole 26 26
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 14047 14047
Pneumothorax 995 995
Hemorrhage/Bleeding 274 274
No Consequences Or Impact To Patient 274 274
Bacterial Infection 172 172
Unspecified Infection 159 159
Foreign Body In Patient 120 120
Insufficient Information 119 119
Fungal Infection 89 89
Cardiac Arrest 84 84
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 38 38
Respiratory Failure 36 36
Bradycardia 34 34
Low Blood Pressure/ Hypotension 32 32
Myocardial Infarction 29 29
Low Oxygen Saturation 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
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
Convulsion/Seizure 16 16
Arrhythmia 15 15
Respiratory Arrest 13 13
Device Embedded In Tissue or Plaque 11 11
Pleural Effusion 11 11
High Blood Pressure/ Hypertension 11 11
Unspecified Respiratory Problem 10 10
Pain 9 9
Bronchial Hemorrhage 9 9
Respiratory Insufficiency 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 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 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 Olympus Corporation of the Americas I Feb-11-2025
21 Olympus Corporation of the Americas II Dec-14-2023
22 Olympus Corporation of the Americas I Nov-09-2023
23 Olympus Corporation of the Americas II Aug-31-2023
24 Olympus Corporation of the Americas II Aug-04-2023
25 Olympus Corporation of the Americas I Jul-17-2023
26 Olympus Corporation of the Americas II May-06-2022
27 Olympus Corporation of the Americas II Sep-24-2021
28 Olympus Corporation of the Americas II Sep-21-2021
29 Olympus Corporation of the Americas II Sep-25-2020
30 Prodimed Plastimed Division II Jul-04-2020
31 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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