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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ultrasound bronchoscope
Definition An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. 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 CodePSV
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 16 16
2017 15 15
2018 37 37
2019 23 23
2020 149 149
2021 134 134
2022 367 367
2023 717 717
2024 146 146

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 420 420
Break 138 138
Detachment of Device or Device Component 129 129
Microbial Contamination of Device 114 114
Device Reprocessing Problem 100 100
Failure to Clean Adequately 93 93
Communication or Transmission Problem 92 92
Peeled/Delaminated 76 76
Adverse Event Without Identified Device or Use Problem 69 69
Material Rupture 52 52
Poor Quality Image 50 50
Leak/Splash 38 38
Material Puncture/Hole 32 32
Material Split, Cut or Torn 31 31
Fluid/Blood Leak 30 30
Material Separation 27 27
Separation Problem 22 22
Device Dislodged or Dislocated 19 19
Contamination 18 18
Loose or Intermittent Connection 14 14
Component Missing 14 14
Mechanical Problem 13 13
Contamination /Decontamination Problem 13 13
Display or Visual Feedback Problem 11 11
Use of Device Problem 11 11
Scratched Material 10 10
Device Fell 9 9
Device Slipped 9 9
Defective Device 8 8
Device Damaged by Another Device 8 8
Material Discolored 7 7
Physical Resistance/Sticking 7 7
Deflation Problem 6 6
Material Fragmentation 6 6
Image Display Error/Artifact 6 6
Material Deformation 6 6
Erratic or Intermittent Display 6 6
Fitting Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Crack 4 4
Unintended Movement 4 4
Corroded 3 3
Detachment Of Device Component 3 3
Defective Component 3 3
Improper or Incorrect Procedure or Method 3 3
Material Perforation 2 2
Obstruction of Flow 2 2
Dent in Material 2 2
Product Quality Problem 2 2
Connection Problem 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Component Falling 2 2
Partial Blockage 2 2
Disconnection 2 2
Image Orientation Incorrect 2 2
Electrical /Electronic Property Problem 2 2
Migration or Expulsion of Device 2 2
Moisture Damage 2 2
Optical Problem 2 2
Output Problem 2 2
Protective Measures Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Explosion 1 1
Sharp Edges 1 1
Failure to Eject 1 1
Incomplete or Inadequate Connection 1 1
Premature Separation 1 1
Failure to Deflate 1 1
Fracture 1 1
Material Opacification 1 1
No Device Output 1 1
Unintended Ejection 1 1
Flaked 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Degraded 1 1
Positioning Failure 1 1
Intermittent Continuity 1 1
Signal Artifact/Noise 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Collapse 1 1
Material Protrusion/Extrusion 1 1
Gas/Air Leak 1 1
Electrical Shorting 1 1
Activation, Positioning or Separation Problem 1 1
Component or Accessory Incompatibility 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Read Input Signal 1 1
Fungus in Device Environment 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1222 1222
No Consequences Or Impact To Patient 99 99
No Patient Involvement 67 67
No Known Impact Or Consequence To Patient 46 46
Fungal Infection 39 39
Foreign Body In Patient 37 37
Bacterial Infection 29 29
Hemorrhage/Bleeding 18 18
Unspecified Infection 15 15
Pneumonia 13 13
Pneumothorax 11 11
Insufficient Information 10 10
Respiratory Tract Infection 9 9
Hypoxia 7 7
Respiratory Failure 6 6
Fever 6 6
Airway Obstruction 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Device Embedded In Tissue or Plaque 6 6
Cardiac Arrest 5 5
Dyspnea 5 5
Hemoptysis 5 5
Low Blood Pressure/ Hypotension 3 3
Sleep Dysfunction 3 3
Bronchospasm 2 2
Fibrosis 2 2
No Information 2 2
Patient Problem/Medical Problem 2 2
Cough 2 2
Respiratory Insufficiency 2 2
Unspecified Tissue Injury 2 2
Sepsis 2 2
Decreased Respiratory Rate 2 2
Perforation of Vessels 2 2
Hematoma 2 2
Pulmonary Emphysema 2 2
Chest Pain 2 2
Death 2 2
Abscess 2 2
Air Embolism 2 2
Arrhythmia 1 1
Asthma 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Vomiting 1 1
Subclinical Infection 1 1
Sore Throat 1 1
Shaking/Tremors 1 1
Septic Shock 1 1
Oversedation 1 1
Swelling/ Edema 1 1
Wheezing 1 1
Unspecified Respiratory Problem 1 1
Unspecified Eye / Vision Problem 1 1
Pleural Empyema 1 1
Cancer 1 1
Syncope/Fainting 1 1
Weight Changes 1 1
Confusion/ Disorientation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Olympus Corporation of the Americas II Aug-31-2023
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