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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
2019 23 23
2020 149 149
2021 134 134
2022 367 367
2023 717 717
2024 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 434 434
Detachment of Device or Device Component 140 140
Break 133 133
Device Reprocessing Problem 102 102
Communication or Transmission Problem 98 98
Microbial Contamination of Device 98 98
Failure to Clean Adequately 97 97
Peeled/Delaminated 76 76
Poor Quality Image 54 54
Material Rupture 51 51
Adverse Event Without Identified Device or Use Problem 48 48
Leak/Splash 39 39
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 15 15
Mechanical Problem 14 14
Component Missing 14 14
Use of Device Problem 11 11
Contamination /Decontamination Problem 11 11
Display or Visual Feedback 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
Physical Resistance/Sticking 8 8
Material Discolored 7 7
Image Display Error/Artifact 7 7
Erratic or Intermittent Display 6 6
Deflation Problem 6 6
Material Deformation 6 6
Crack 5 5
Material Fragmentation 4 4
Device Contamination with Chemical or Other Material 4 4
Fitting Problem 4 4
Unintended Movement 4 4
Material Twisted/Bent 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Material Too Rigid or Stiff 3 3
Corroded 3 3
Degraded 2 2
Electrical /Electronic Property Problem 2 2
Partial Blockage 2 2
Moisture Damage 2 2
Image Orientation Incorrect 2 2
Disconnection 2 2
Product Quality Problem 2 2
Dent in Material 2 2
Optical Problem 2 2
Output Problem 2 2
Connection Problem 2 2
Mechanical Jam 2 2
Premature Separation 2 2
Failure to Deflate 1 1
Sharp Edges 1 1
Incomplete or Inadequate Connection 1 1
Failure to Eject 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Explosion 1 1
Activation, Positioning or Separation Problem 1 1
Component or Accessory Incompatibility 1 1
Protective Measures Problem 1 1
Gas/Air Leak 1 1
Electrical Shorting 1 1
Obstruction of Flow 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Read Input Signal 1 1
Fracture 1 1
Inflation Problem 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Opacification 1 1
No Device Output 1 1
Signal Artifact/Noise 1 1
Burst Container or Vessel 1 1
Intermittent Continuity 1 1
Complete Blockage 1 1
Collapse 1 1
Unintended Ejection 1 1
Flaked 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1275 1275
No Consequences Or Impact To Patient 86 86
No Patient Involvement 65 65
Foreign Body In Patient 37 37
Fungal Infection 27 27
Bacterial Infection 27 27
No Known Impact Or Consequence To Patient 23 23
Hemorrhage/Bleeding 16 16
Pneumonia 13 13
Pneumothorax 11 11
Unspecified Infection 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
Cardiac Arrest 5 5
Dyspnea 5 5
Hemoptysis 5 5
Low Blood Pressure/ Hypotension 3 3
Sleep Dysfunction 3 3
Bronchospasm 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 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
Abscess 2 2
Air Embolism 2 2
Arrhythmia 1 1
Asthma 1 1
Death 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
Laceration(s) 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
No Information 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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