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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
AURIS SURGICAL ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
BODY VISION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTS
  SUBSTANTIALLY EQUIVALENT 1
NOAH MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 9
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 5
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 279 279
2019 654 654
2020 515 515
2021 1357 1357
2022 2537 2537
2023 3205 3205

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1812 1812
Peeled/Delaminated 1231 1231
No Display/Image 1225 1225
Adverse Event Without Identified Device or Use Problem 1145 1145
Communication or Transmission Problem 573 573
Fluid/Blood Leak 465 465
Microbial Contamination of Device 439 439
Device Reprocessing Problem 221 221
Loose or Intermittent Connection 166 166
Detachment of Device or Device Component 157 157
Failure to Clean Adequately 135 135
Display or Visual Feedback Problem 114 114
Poor Quality Image 110 110
Erratic or Intermittent Display 88 88
Contamination 66 66
Obstruction of Flow 63 63
Unintended Movement 63 63
Degraded 62 62
Material Split, Cut or Torn 62 62
Contamination /Decontamination Problem 58 58
Material Deformation 55 55
Optical Obstruction 50 50
Insufficient Information 49 49
Image Display Error/Artifact 47 47
Electrical /Electronic Property Problem 46 46
Material Separation 45 45
Optical Problem 40 40
Leak/Splash 36 36
Mechanical Problem 33 33
Material Twisted/Bent 32 32
Difficult to Open or Close 32 32
Component Missing 31 31
Optical Distortion 30 30
Scratched Material 29 29
Defective Device 28 28
Device Contamination with Chemical or Other Material 27 27
Material Fragmentation 27 27
Physical Resistance/Sticking 26 26
Fracture 25 25
Difficult to Remove 23 23
Failure to Power Up 21 21
Appropriate Term/Code Not Available 21 21
Corroded 19 19
Material Integrity Problem 18 18
Output Problem 17 17
Entrapment of Device 17 17
Use of Device Problem 15 15
Retraction Problem 13 13
Failure to Disconnect 11 11
Device Fell 11 11
Device Damaged by Another Device 10 10
Partial Blockage 10 10
Material Puncture/Hole 9 9
Mechanical Jam 9 9
Gas/Air Leak 9 9
Defective Component 9 9
Residue After Decontamination 9 9
Connection Problem 8 8
Deformation Due to Compressive Stress 7 7
Failure to Advance 7 7
Dent in Material 7 7
Energy Output Problem 7 7
No Device Output 7 7
Crack 7 7
Collapse 6 6
Detachment Of Device Component 6 6
Disconnection 6 6
Suction Problem 6 6
Difficult to Advance 6 6
Device Dislodged or Dislocated 6 6
Device-Device Incompatibility 5 5
Power Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Structural Problem 5 5
Activation, Positioning or Separation Problem 5 5
Thermal Decomposition of Device 5 5
Overheating of Device 5 5
Moisture Damage 5 5
Unexpected Shutdown 5 5
Failure to Eject 5 5
Device Handling Problem 4 4
Suction Failure 4 4
Unintended Application Program Shut Down 4 4
Separation Problem 4 4
Melted 4 4
Biofilm coating in Device 4 4
Flaked 4 4
Fire 3 3
Component Incompatible 3 3
Intermittent Continuity 3 3
Product Quality Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Off-Label Use 3 3
Stretched 3 3
Failure to Obtain Sample 3 3
Failure to Sense 3 3
Visual Prompts will not Clear 3 3
Device Damaged Prior to Use 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5879 5879
No Consequences Or Impact To Patient 678 678
Pneumothorax 573 573
Unspecified Infection 282 282
No Known Impact Or Consequence To Patient 235 235
Bacterial Infection 217 217
Hemorrhage/Bleeding 155 155
Insufficient Information 91 91
Foreign Body In Patient 78 78
No Patient Involvement 70 70
Fungal Infection 67 67
Pneumonia 46 46
Respiratory Tract Infection 45 45
Cardiac Arrest 44 44
Hypoxia 33 33
Injury 24 24
Death 22 22
Device Embedded In Tissue or Plaque 19 19
Low Oxygen Saturation 17 17
Chest Pain 16 16
Viral Infection 16 16
Myocardial Infarction 15 15
Stroke/CVA 15 15
Fever 15 15
Dyspnea 15 15
Low Blood Pressure/ Hypotension 15 15
Respiratory Failure 14 14
No Information 14 14
Blood Loss 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Bradycardia 12 12
Air Embolism 8 8
Hemoptysis 8 8
Inflammation 8 8
Convulsion/Seizure 8 8
Unspecified Respiratory Problem 7 7
No Code Available 6 6
Pain 6 6
High Blood Pressure/ Hypertension 6 6
Arrhythmia 6 6
Airway Obstruction 5 5
Perforation 5 5
Bronchial Hemorrhage 5 5
Respiratory Arrest 5 5
Unspecified Tissue Injury 4 4
Pleural Effusion 4 4
Hypersensitivity/Allergic reaction 4 4
Hematoma 3 3
Non specific EKG/ECG Changes 3 3
Abdominal Pain 3 3
Abscess 3 3
Laceration(s) 3 3
Ventilator Dependent 3 3
Unintended Extubation 3 3
Unintended Radiation Exposure 3 3
Cough 3 3
Asystole 3 3
Patient Problem/Medical Problem 3 3
Bronchospasm 2 2
Decreased Respiratory Rate 2 2
Heart Block 2 2
Unspecified Heart Problem 2 2
Gastrointestinal Hemorrhage 2 2
Pancreatitis 2 2
Genital Bleeding 2 2
Drug Resistant Bacterial Infection 2 2
Sore Throat 2 2
Coma 2 2
Brain Injury 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Tissue Damage 2 2
Transient Ischemic Attack 2 2
Ventricular Fibrillation 2 2
Vomiting 2 2
Oversedation 2 2
Paralysis 2 2
Suffocation 2 2
Asthma 2 2
Atrial Fibrillation 2 2
Abnormal Blood Gases 2 2
Burn(s) 2 2
Hypovolemic Shock 2 2
Hemothorax 1 1
Fatigue 1 1
Foreign Body Reaction 1 1
Cardiomyopathy 1 1
Cardiopulmonary Arrest 1 1
Bronchitis 1 1
Exposure to Body Fluids 1 1
Aspiration/Inhalation 1 1
Adult Respiratory Distress Syndrome 1 1
Tachycardia 1 1
Pulmonary Infarction 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Shock 1 1
Chills 1 1
Urinary Retention 1 1
Peritonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Nov-16-2019
2 Aizu Olympus Co., Ltd. II Aug-19-2022
3 Aomori Olympus Co., Ltd. II Feb-05-2021
4 Intuitive Surgical, Inc. II Oct-15-2021
5 Intuitive Surgical, Inc. II Nov-25-2020
6 Intuitive Surgical, Inc. II Sep-10-2020
7 Karl Storz Endoscopy II Sep-15-2023
8 Karl Storz Endoscopy II May-10-2022
9 Karl Storz Endoscopy II Aug-31-2019
10 Lymol Medical Corporation II Sep-24-2021
11 Olympus Corporation of the Americas II Aug-31-2023
12 Olympus Corporation of the Americas II Aug-04-2023
13 Olympus Corporation of the Americas I Jul-17-2023
14 Olympus Corporation of the Americas II May-06-2022
15 Olympus Corporation of the Americas II Sep-24-2021
16 Olympus Corporation of the Americas II Sep-21-2021
17 Olympus Corporation of the Americas II Sep-25-2020
18 Olympus Corporation of the Americas II Aug-02-2019
19 Olympus Corporation of the Americas II Sep-29-2018
20 Prodimed Plastimed Division II Jul-04-2020
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