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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 2
ANREI MEDICAL (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURIS SURGICAL ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AXESS VISION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
BODY VISION MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 1
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 7
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERAN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON MEDICAL (CANADA) ULC
  SUBSTANTIALLY EQUIVALENT 3
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 297 297
2017 336 336
2018 279 279
2019 654 654
2020 515 515
2021 340 340

Device Problems MDRs with this Device Problem Events in those MDRs
Break 736 736
Adverse Event Without Identified Device or Use Problem 480 480
Microbial Contamination of Device 334 334
Appropriate Term/Code Not Available 137 137
Bent 80 80
Device Reprocessing Problem 60 60
Loose or Intermittent Connection 60 60
Detachment of Device or Device Component 56 56
Device Issue 49 49
Insufficient Information 43 43
No Display/Image 27 27
Fluid Leak 26 26
Contamination /Decontamination Problem 26 26
Detachment Of Device Component 25 25
Nonstandard Device 25 25
Material Puncture/Hole 22 22
Peeled/Delaminated 21 21
Electrical /Electronic Property Problem 18 18
Material Separation 18 18
Fracture 17 17
Material Fragmentation 16 16
Contamination 16 16
Material Deformation 16 16
Material Split, Cut or Torn 14 14
Difficult to Remove 13 13
Leak/Splash 13 13
Material Twisted/Bent 12 12
Defective Device 12 12
Difficult to Open or Close 10 10
Failure to Power Up 10 10
Component Missing 10 10
Entrapment of Device 10 10
Device Contamination with Chemical or Other Material 10 10
Poor Quality Image 9 9
Display or Visual Feedback Problem 9 9
Use of Device Problem 8 8
Device Operates Differently Than Expected 8 8
Failure to Clean Adequately 8 8
Mechanical Problem 7 7
Device Contamination With Biological Material 6 6
Device Disinfection Or Sterilization Issue 6 6
Material Integrity Problem 5 5
Device Fell 5 5
Improper or Incorrect Procedure or Method 5 5
Failure to Advance 5 5
Suction Problem 5 5
Device Damaged by Another Device 5 5
Device Dislodged or Dislocated 4 4
Communication or Transmission Problem 4 4
Biofilm coating in Device 4 4
Erratic or Intermittent Display 4 4
Physical Resistance/Sticking 4 4
Difficult to Advance 4 4
Failure to Disconnect 4 4
Difficult to Insert 3 3
Image Display Error/Artifact 3 3
Thermal Decomposition of Device 3 3
Dent in Material 3 3
Energy Output Problem 3 3
Defective Component 3 3
Structural Problem 3 3
Obstruction of Flow 3 3
Mechanical Jam 3 3
Device Handling Problem 3 3
Output Problem 3 3
Material Perforation 3 3
Retraction Problem 3 3
Failure to Sense 3 3
Loss of or Failure to Bond 3 3
Component Incompatible 3 3
Crack 2 2
Unintended Ejection 2 2
Material Disintegration 2 2
Inflation Problem 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Overheating of Device 2 2
Device Slipped 2 2
Smoking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation, Positioning or SeparationProblem 2 2
Material Protrusion/Extrusion 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Residue After Decontamination 2 2
Inadequate Service 2 2
Sticking 2 2
Device Inoperable 2 2
Flaked 2 2
Connection Problem 2 2
Positioning Problem 2 2
Suction Failure 2 2
Unintended Movement 2 2
Activation Failure 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Missing Information 1 1
Power Problem 1 1
Scratched Material 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 832 832
Unspecified Infection 392 392
No Known Impact Or Consequence To Patient 326 326
Bacterial Infection 227 227
No Clinical Signs, Symptoms or Conditions 194 194
Pneumothorax 82 82
No Patient Involvement 80 80
Fungal Infection 46 46
Device Embedded In Tissue or Plaque 31 31
Pneumonia 30 30
Injury 29 29
Death 28 28
Foreign Body In Patient 24 24
No Code Available 23 23
No Information 22 22
Hemorrhage/Bleeding 22 22
Blood Loss 19 19
Respiratory Tract Infection 15 15
Insufficient Information 13 13
Viral Infection 8 8
Inflammation 8 8
Patient Problem/Medical Problem 6 6
Hypoxia 5 5
Myocardial Infarction 4 4
Perforation 4 4
Dyspnea 4 4
Abscess 3 3
Pain 3 3
Cardiac Arrest 3 3
Chest Pain 2 2
Abnormal Blood Gases 2 2
Burn, Thermal 2 2
Suffocation 2 2
Tissue Damage 2 2
Pulmonary Embolism 2 2
Burn(s) 2 2
Fever 2 2
Hematoma 2 2
Cancer 2 2
Bronchial Hemorrhage 2 2
Cough 2 2
Unspecified Heart Problem 1 1
Extubate 1 1
Chills 1 1
Low Oxygen Saturation 1 1
Skin Tears 1 1
Superficial (First Degree) Burn 1 1
Cardiopulmonary Arrest 1 1
Fatigue 1 1
Abrasion 1 1
Airway Obstruction 1 1
Vomiting 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Stenosis 1 1
Discomfort 1 1
Pulmonary Infarction 1 1
Respiratory Distress 1 1
Seizures 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Sore Throat 1 1
Laceration(s) 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Edema 1 1
Eye Injury 1 1
Hemoptysis 1 1
Paralysis 1 1
Pleural Effusion 1 1
Pseudoaneurysm 1 1
Intraoperative Pain 1 1
Respiratory Arrest 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 Nov-25-2020
4 Intuitive Surgical, Inc. II Sep-10-2020
5 Karl Storz Endoscopy II Aug-31-2019
6 Olympus Corporation of the Americas II Sep-25-2020
7 Olympus Corporation of the Americas II Aug-02-2019
8 Olympus Corporation of the Americas II Sep-29-2018
9 Pentax Medical Company II Jun-28-2016
10 Pentax of America Inc II Jun-09-2017
11 Pentax of America Inc II Dec-14-2016
12 Pentax of America Inc II Sep-22-2016
13 Prodimed Plastimed Division II Jul-04-2020
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