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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 1
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 2537 2537
2023 5041 5041
2024 1896 1896

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 2532 2532
Break 2027 2027
Peeled/Delaminated 1787 1787
Adverse Event Without Identified Device or Use Problem 1562 1562
Communication or Transmission Problem 1152 1152
Microbial Contamination of Device 613 613
Fluid/Blood Leak 599 599
Device Reprocessing Problem 295 295
Failure to Clean Adequately 255 255
Detachment of Device or Device Component 223 223
Poor Quality Image 220 220
Loose or Intermittent Connection 199 199
Erratic or Intermittent Display 173 173
Appropriate Term/Code Not Available 151 151
Display or Visual Feedback Problem 135 135
Optical Obstruction 120 120
Contamination 99 99
Bent 92 92
Obstruction of Flow 88 88
Contamination /Decontamination Problem 82 82
Material Split, Cut or Torn 79 79
Insufficient Information 79 79
Material Deformation 77 77
Thermal Decomposition of Device 75 75
Degraded 75 75
Image Display Error/Artifact 72 72
Unintended Movement 68 68
Optical Problem 66 66
Leak/Splash 58 58
Material Separation 58 58
Device Issue 49 49
Electrical /Electronic Property Problem 49 49
Mechanical Problem 46 46
Melted 45 45
Material Fragmentation 40 40
Component Missing 40 40
Scratched Material 40 40
Difficult to Open or Close 39 39
Detachment Of Device Component 37 37
Difficult to Remove 36 36
Defective Device 33 33
Corroded 33 33
Material Twisted/Bent 33 33
Optical Distortion 32 32
Fracture 32 32
Device Contamination with Chemical or Other Material 32 32
Material Puncture/Hole 31 31
Physical Resistance/Sticking 31 31
Output Problem 27 27
Failure to Power Up 27 27
Nonstandard Device 26 26
Defective Component 25 25
Material Integrity Problem 24 24
Use of Device Problem 22 22
Entrapment of Device 22 22
Overheating of Device 20 20
Device Disinfection Or Sterilization Issue 20 20
Device Damaged by Another Device 16 16
Retraction Problem 15 15
Improper or Incorrect Procedure or Method 14 14
Device Operates Differently Than Expected 13 13
No Visual Prompts/Feedback 13 13
Mechanical Jam 11 11
Device Fell 11 11
Failure to Disconnect 11 11
Dent in Material 10 10
Deformation Due to Compressive Stress 10 10
Difficult to Advance 10 10
Device Dislodged or Dislocated 10 10
Crack 10 10
Partial Blockage 10 10
Signal Artifact/Noise 9 9
Disconnection 9 9
Gas/Air Leak 9 9
Connection Problem 9 9
Residue After Decontamination 9 9
Failure to Advance 9 9
Device Handling Problem 9 9
Suction Problem 8 8
Collapse 8 8
Component Incompatible 8 8
No Device Output 8 8
Energy Output Problem 7 7
Fire 7 7
Flaked 7 7
Material Disintegration 7 7
Device-Device Incompatibility 7 7
Naturally Worn 7 7
Excessive Heating 7 7
Unexpected Shutdown 6 6
Device Contamination With Biological Material 6 6
Loss of or Failure to Bond 6 6
Difficult to Insert 6 6
Moisture Damage 5 5
Activation, Positioning or Separation Problem 5 5
Material Rupture 5 5
Stretched 5 5
Structural Problem 5 5
Positioning Problem 5 5
Power Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9268 9268
No Consequences Or Impact To Patient 887 887
Pneumothorax 786 786
Unspecified Infection 509 509
Bacterial Infection 391 391
No Known Impact Or Consequence To Patient 347 347
Hemorrhage/Bleeding 221 221
Fungal Infection 109 109
Foreign Body In Patient 101 101
Insufficient Information 96 96
No Patient Involvement 81 81
Pneumonia 65 65
Cardiac Arrest 61 61
Respiratory Tract Infection 51 51
Device Embedded In Tissue or Plaque 48 48
Hypoxia 45 45
Death 33 33
No Information 32 32
Injury 30 30
Respiratory Failure 27 27
No Code Available 27 27
Low Oxygen Saturation 25 25
Low Blood Pressure/ Hypotension 25 25
Dyspnea 23 23
Bradycardia 23 23
Fever 22 22
Myocardial Infarction 22 22
Viral Infection 22 22
Blood Loss 20 20
Stroke/CVA 20 20
Chest Pain 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Hemoptysis 16 16
Air Embolism 13 13
Airway Obstruction 11 11
Arrhythmia 11 11
High Blood Pressure/ Hypertension 10 10
Pain 10 10
Unspecified Respiratory Problem 10 10
Convulsion/Seizure 9 9
Inflammation 9 9
Perforation 8 8
Respiratory Arrest 8 8
Cough 7 7
Burn(s) 7 7
Non specific EKG/ECG Changes 7 7
Bronchial Hemorrhage 6 6
Respiratory Insufficiency 6 6
Drug Resistant Bacterial Infection 6 6
Patient Problem/Medical Problem 6 6
Bronchospasm 5 5
Sore Throat 5 5
Unspecified Tissue Injury 5 5
Asystole 5 5
Hypersensitivity/Allergic reaction 5 5
Pleural Effusion 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Ventricular Fibrillation 4 4
Vomiting 4 4
Fibrosis 4 4
Ventilator Dependent 4 4
Burn, Thermal 3 3
Cancer 3 3
Unintended Extubation 3 3
Unintended Radiation Exposure 3 3
Hematemesis 3 3
Shock 3 3
Tissue Damage 3 3
Oversedation 3 3
Laceration(s) 3 3
Fungus 3 3
Hematoma 3 3
Aspiration/Inhalation 3 3
Pulmonary Embolism 3 3
Abdominal Pain 3 3
Abscess 3 3
Asthma 2 2
Atrial Fibrillation 2 2
Cardiomyopathy 2 2
Exposure to Body Fluids 2 2
Abnormal Blood Gases 2 2
Headache 2 2
Hemothorax 2 2
Hypovolemic Shock 2 2
Paralysis 2 2
Transient Ischemic Attack 2 2
Suffocation 2 2
Tachycardia 2 2
Respiratory Distress 2 2
Sepsis 2 2
Septic Shock 2 2
Chills 2 2
Infection, Indirect 2 2
Brain Injury 2 2
Pancreatitis 2 2
Genital Bleeding 2 2
Gastrointestinal Hemorrhage 2 2
Decreased Appetite 2 2
Syncope/Fainting 2 2
Heart Block 2 2

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 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 Olympus Corporation of the Americas II Sep-29-2018
29 Pentax Medical Company II Jun-28-2016
30 Pentax Medical Company II Jan-20-2012
31 Pentax of America Inc II Jun-09-2017
32 Pentax of America Inc II Dec-14-2016
33 Pentax of America Inc II Sep-22-2016
34 Prodimed Plastimed Division II Jul-04-2020
35 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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