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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 3
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
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 8
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 4
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 336 336
2018 279 279
2019 654 654
2020 515 515
2021 1359 1359
2022 1301 1301

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1467 1467
Adverse Event Without Identified Device or Use Problem 737 737
Peeled/Delaminated 422 422
Microbial Contamination of Device 374 374
Fluid Leak 216 216
Appropriate Term/Code Not Available 141 141
Device Reprocessing Problem 105 105
Loose or Intermittent Connection 103 103
Detachment of Device or Device Component 79 79
No Display/Image 73 73
Contamination /Decontamination Problem 64 64
Unintended Movement 51 51
Bent 46 46
Insufficient Information 42 42
Contamination 40 40
Display or Visual Feedback Problem 34 34
Material Split, Cut or Torn 31 31
Failure to Clean Adequately 31 31
Electrical /Electronic Property Problem 30 30
Fracture 29 29
Leak/Splash 28 28
Material Deformation 28 28
Degraded 27 27
Nonstandard Device 25 25
Material Separation 25 25
Obstruction of Flow 25 25
Material Fragmentation 24 24
Material Twisted/Bent 23 23
Communication or Transmission Problem 22 22
Poor Quality Image 22 22
Defective Device 21 21
Physical Resistance/Sticking 20 20
Difficult to Open or Close 19 19
Device Contamination with Chemical or Other Material 18 18
Component Missing 17 17
Failure to Power Up 17 17
Entrapment of Device 17 17
Detachment Of Device Component 17 17
Difficult to Remove 16 16
Optical Distortion 14 14
Scratched Material 12 12
Mechanical Problem 12 12
Material Puncture/Hole 11 11
Erratic or Intermittent Display 11 11
Device Issue 10 10
Device Fell 10 10
Residue After Decontamination 9 9
Failure to Disconnect 9 9
Use of Device Problem 9 9
Retraction Problem 8 8
Image Display Error/Artifact 8 8
Suction Problem 7 7
Optical Problem 7 7
Output Problem 6 6
Difficult to Advance 6 6
Mechanical Jam 6 6
Material Integrity Problem 6 6
Device Contamination With Biological Material 6 6
Corroded 6 6
Improper or Incorrect Procedure or Method 6 6
Energy Output Problem 6 6
Crack 5 5
Collapse 5 5
Defective Component 5 5
Device Operates Differently Than Expected 5 5
Gas Leak 5 5
Device Dislodged or Dislocated 5 5
Device Damaged by Another Device 4 4
Device Handling Problem 4 4
Structural Problem 4 4
Deformation Due to Compressive Stress 4 4
Connection Problem 4 4
Failure to Advance 4 4
Biofilm coating in Device 4 4
No Device Output 4 4
Overheating of Device 4 4
Unintended Application Program Shut Down 4 4
Failure to Eject 3 3
Separation Problem 3 3
Failure to Sense 3 3
Partial Blockage 3 3
Thermal Decomposition of Device 3 3
Component Incompatible 3 3
Flaked 3 3
Dent in Material 3 3
Activation, Positioning or SeparationProblem 3 3
Device Disinfection Or Sterilization Issue 3 3
Material Protrusion/Extrusion 3 3
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Device Inoperable 2 2
Fitting Problem 2 2
Visual Prompts will not Clear 2 2
Device Damaged Prior to Use 2 2
Unintended Ejection 2 2
Material Rupture 2 2
Smoking 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Difficult to Insert 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2002 2002
No Consequences Or Impact To Patient 750 750
Unspecified Infection 419 419
Pneumothorax 301 301
No Known Impact Or Consequence To Patient 279 279
Bacterial Infection 148 148
Hemorrhage/Bleeding 85 85
No Patient Involvement 73 73
Foreign Body In Patient 55 55
Insufficient Information 54 54
Respiratory Tract Infection 43 43
Pneumonia 40 40
Fungal Infection 39 39
Injury 27 27
Device Embedded In Tissue or Plaque 25 25
No Code Available 22 22
Death 22 22
Hypoxia 18 18
Cardiac Arrest 16 16
Blood Loss 16 16
No Information 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Chest Pain 10 10
Myocardial Infarction 9 9
Inflammation 8 8
Viral Infection 8 8
Low Oxygen Saturation 8 8
Low Blood Pressure/ Hypotension 7 7
Dyspnea 6 6
Stroke/CVA 6 6
Fever 6 6
Bradycardia 6 6
Pain 5 5
Respiratory Failure 5 5
Bronchial Hemorrhage 5 5
Perforation 4 4
Abscess 4 4
High Blood Pressure/ Hypertension 4 4
Hematoma 3 3
Airway Obstruction 3 3
Arrhythmia 3 3
Laceration(s) 3 3
Cough 3 3
Patient Problem/Medical Problem 3 3
Bronchospasm 2 2
Convulsion/Seizure 2 2
Unspecified Respiratory Problem 2 2
Heart Block 2 2
Unspecified Heart Problem 2 2
Pancreatitis 2 2
Oversedation 2 2
Paralysis 2 2
Ventricular Fibrillation 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Suffocation 2 2
Tissue Damage 2 2
Coma 2 2
Abnormal Blood Gases 2 2
Pulmonary Embolism 2 2
Asthma 2 2
Hypersensitivity/Allergic reaction 2 2
Air Embolism 2 2
Foreign Body Reaction 1 1
Non specific EKG/ECG Changes 1 1
Edema 1 1
Eye Injury 1 1
Fatigue 1 1
Hemoptysis 1 1
Atrial Fibrillation 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Abdominal Pain 1 1
Abrasion 1 1
Aspiration/Inhalation 1 1
Adult Respiratory Distress Syndrome 1 1
Obstruction/Occlusion 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Extubate 1 1
Transient Ischemic Attack 1 1
Stenosis 1 1
Anxiety 1 1
Discomfort 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Chills 1 1
Pulmonary Infarction 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Shock 1 1
Pleural Effusion 1 1
Unintended Extubation 1 1
Unintended Radiation Exposure 1 1
Hematemesis 1 1
Respiratory Arrest 1 1
Ischemia Stroke 1 1
Unspecified Blood or Lymphatic problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Nov-16-2019
2 Aomori Olympus Co., Ltd. II Feb-05-2021
3 Intuitive Surgical, Inc. II Oct-15-2021
4 Intuitive Surgical, Inc. II Nov-25-2020
5 Intuitive Surgical, Inc. II Sep-10-2020
6 Karl Storz Endoscopy II May-10-2022
7 Karl Storz Endoscopy II Aug-31-2019
8 Lymol Medical Corporation II Sep-24-2021
9 Olympus Corporation of the Americas II May-06-2022
10 Olympus Corporation of the Americas II Sep-24-2021
11 Olympus Corporation of the Americas II Sep-21-2021
12 Olympus Corporation of the Americas II Sep-25-2020
13 Olympus Corporation of the Americas II Aug-02-2019
14 Olympus Corporation of the Americas II Sep-29-2018
15 Pentax of America Inc II Jun-09-2017
16 Prodimed Plastimed Division II Jul-04-2020
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