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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 CORPORATON
  SUBSTANTIALLY EQUIVALENT 1
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 9
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SERPEX MEDICAL, INC.
  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 2032 2032

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1589 1589
Adverse Event Without Identified Device or Use Problem 817 817
Peeled/Delaminated 630 630
Microbial Contamination of Device 385 385
Fluid/Blood Leak 286 286
Appropriate Term/Code Not Available 143 143
Device Reprocessing Problem 121 121
Loose or Intermittent Connection 114 114
Communication or Transmission Problem 102 102
No Display/Image 100 100
Detachment of Device or Device Component 96 96
Contamination /Decontamination Problem 65 65
Display or Visual Feedback Problem 55 55
Unintended Movement 52 52
Contamination 51 51
Failure to Clean Adequately 48 48
Bent 46 46
Insufficient Information 42 42
Material Split, Cut or Torn 38 38
Degraded 36 36
Obstruction of Flow 36 36
Material Deformation 34 34
Material Separation 31 31
Electrical /Electronic Property Problem 30 30
Fracture 29 29
Leak/Splash 29 29
Material Fragmentation 27 27
Material Twisted/Bent 26 26
Poor Quality Image 25 25
Nonstandard Device 25 25
Failure to Power Up 21 21
Device Contamination with Chemical or Other Material 21 21
Defective Device 21 21
Physical Resistance/Sticking 21 21
Difficult to Open or Close 20 20
Optical Distortion 19 19
Mechanical Problem 18 18
Entrapment of Device 17 17
Detachment Of Device Component 17 17
Component Missing 17 17
Difficult to Remove 16 16
Scratched Material 13 13
Image Display Error/Artifact 12 12
Erratic or Intermittent Display 12 12
Material Puncture/Hole 11 11
Optical Problem 11 11
Use of Device Problem 11 11
Device Fell 11 11
Device Issue 10 10
Corroded 10 10
Retraction Problem 9 9
Residue After Decontamination 9 9
Failure to Disconnect 9 9
Mechanical Jam 8 8
Material Integrity Problem 7 7
Suction Problem 7 7
Energy Output Problem 7 7
Overheating of Device 6 6
Collapse 6 6
Improper or Incorrect Procedure or Method 6 6
Device Contamination With Biological Material 6 6
Connection Problem 6 6
Difficult to Advance 6 6
Output Problem 6 6
Device Operates Differently Than Expected 5 5
Device Dislodged or Dislocated 5 5
Gas/Air Leak 5 5
Dent in Material 5 5
Deformation Due to Compressive Stress 5 5
Defective Component 5 5
Crack 5 5
Biofilm coating in Device 4 4
Partial Blockage 4 4
No Device Output 4 4
Moisture Damage 4 4
Failure to Advance 4 4
Structural Problem 4 4
Device Damaged by Another Device 4 4
Activation, Positioning or Separation Problem 4 4
Device Handling Problem 4 4
Unintended Application Program Shut Down 4 4
Failure to Eject 3 3
Separation Problem 3 3
Material Protrusion/Extrusion 3 3
Device Disinfection Or Sterilization Issue 3 3
Failure to Sense 3 3
Thermal Decomposition of Device 3 3
Component Incompatible 3 3
Flaked 3 3
Unintended Ejection 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 2 2
Smoking 2 2
Product Quality Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Difficult to Insert 2 2
Device Inoperable 2 2
Visual Prompts will not Clear 2 2
Device Damaged Prior to Use 2 2
Fitting Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2640 2640
No Consequences Or Impact To Patient 750 750
Unspecified Infection 420 420
Pneumothorax 361 361
No Known Impact Or Consequence To Patient 279 279
Bacterial Infection 148 148
Hemorrhage/Bleeding 106 106
No Patient Involvement 73 73
Foreign Body In Patient 66 66
Insufficient Information 59 59
Respiratory Tract Infection 44 44
Pneumonia 44 44
Fungal Infection 39 39
Injury 27 27
Device Embedded In Tissue or Plaque 26 26
No Code Available 22 22
Death 22 22
Cardiac Arrest 21 21
Hypoxia 20 20
Blood Loss 16 16
No Information 15 15
Chest Pain 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Dyspnea 11 11
Myocardial Infarction 10 10
Low Blood Pressure/ Hypotension 9 9
Bradycardia 9 9
Low Oxygen Saturation 9 9
Respiratory Failure 9 9
Inflammation 8 8
Viral Infection 8 8
Stroke/CVA 7 7
Fever 7 7
High Blood Pressure/ Hypertension 6 6
Pain 5 5
Bronchial Hemorrhage 5 5
Perforation 4 4
Hemoptysis 4 4
Abscess 4 4
Airway Obstruction 3 3
Arrhythmia 3 3
Hematoma 3 3
Laceration(s) 3 3
Cough 3 3
Respiratory Arrest 3 3
Convulsion/Seizure 3 3
Unintended Radiation Exposure 3 3
Patient Problem/Medical Problem 3 3
Bronchospasm 2 2
Pancreatitis 2 2
Heart Block 2 2
Unspecified Heart Problem 2 2
Unspecified Respiratory Problem 2 2
Oversedation 2 2
Paralysis 2 2
Suffocation 2 2
Tissue Damage 2 2
Urinary Tract Infection 2 2
Ventricular Fibrillation 2 2
Coma 2 2
Chronic Obstructive Pulmonary Disease (COPD) 2 2
Hypersensitivity/Allergic reaction 2 2
Air Embolism 2 2
Abnormal Blood Gases 2 2
Pulmonary Embolism 2 2
Asthma 2 2
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
Foreign Body Reaction 1 1
Non specific EKG/ECG Changes 1 1
Edema 1 1
Eye Injury 1 1
Fatigue 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1
Sore Throat 1 1
Extubate 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Chills 1 1
Stenosis 1 1
Anxiety 1 1
Discomfort 1 1
Transient Ischemic Attack 1 1
Urinary Retention 1 1
Pulmonary Infarction 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Shock 1 1
Pleural Effusion 1 1
Hematemesis 1 1
Aspiration Pneumonitis 1 1
Unintended Extubation 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 May-10-2022
8 Karl Storz Endoscopy II Aug-31-2019
9 Lymol Medical Corporation II Sep-24-2021
10 Olympus Corporation of the Americas II May-06-2022
11 Olympus Corporation of the Americas II Sep-24-2021
12 Olympus Corporation of the Americas II Sep-21-2021
13 Olympus Corporation of the Americas II Sep-25-2020
14 Olympus Corporation of the Americas II Aug-02-2019
15 Olympus Corporation of the Americas II Sep-29-2018
16 Pentax of America Inc II Jun-09-2017
17 Prodimed Plastimed Division II Jul-04-2020
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