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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ultrasound bronchoscope
Regulation Description Ultrasonic pulsed doppler imaging system.
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

MDR Year MDR Reports MDR Events
2020 149 149
2021 134 134
2022 367 367
2023 717 717
2024 627 627
2025 468 468

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 733 733
Detachment of Device or Device Component 231 231
Communication or Transmission Problem 209 209
Break 184 184
Failure to Clean Adequately 180 180
Device Reprocessing Problem 138 138
Microbial Contamination of Device 120 120
Peeled/Delaminated 102 102
Poor Quality Image 101 101
Material Puncture/Hole 73 73
Material Rupture 55 55
Leak/Splash 46 46
Adverse Event Without Identified Device or Use Problem 46 46
Material Split, Cut or Torn 45 45
Fluid/Blood Leak 34 34
Material Separation 34 34
Loose or Intermittent Connection 26 26
Contamination 25 25
Separation Problem 21 21
Display or Visual Feedback Problem 20 20
Device Dislodged or Dislocated 18 18
Component Missing 17 17
Material Deformation 16 16
Image Display Error/Artifact 16 16
Scratched Material 16 16
Mechanical Problem 15 15
Contamination /Decontamination Problem 15 15
Physical Resistance/Sticking 13 13
Device Damaged by Another Device 12 12
Device Slipped 11 11
Use of Device Problem 11 11
Erratic or Intermittent Display 10 10
Device Fell 9 9
Defective Device 8 8
Material Fragmentation 8 8
Material Discolored 8 8
Deflation Problem 7 7
Degraded 7 7
Corroded 7 7
Optical Problem 6 6
Crack 6 6
Connection Problem 6 6
Gas/Air Leak 6 6
Device Contamination with Chemical or Other Material 5 5
Unintended Movement 4 4
Defective Component 4 4
Mechanical Jam 4 4
Fitting Problem 4 4
Material Too Rigid or Stiff 4 4
Output Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2145 2145
No Consequences Or Impact To Patient 80 80
No Patient Involvement 65 65
Foreign Body In Patient 41 41
Bacterial Infection 28 28
Fungal Infection 25 25
Insufficient Information 19 19
Hemorrhage/Bleeding 16 16
Unspecified Infection 13 13
Pneumonia 13 13
No Known Impact Or Consequence To Patient 12 12
Pneumothorax 11 11
Hypoxia 9 9
Respiratory Tract Infection 9 9
Respiratory Failure 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Airway Obstruction 6 6
Fever 6 6
Hemoptysis 5 5
Cardiac Arrest 5 5
Dyspnea 5 5
Low Blood Pressure/ Hypotension 3 3
Sleep Dysfunction 3 3
Decreased Respiratory Rate 2 2
Respiratory Insufficiency 2 2
Fibrosis 2 2
Unspecified Tissue Injury 2 2
Bronchospasm 2 2
Perforation of Vessels 2 2
Cough 2 2
Abscess 2 2
Chest Pain 2 2
Pulmonary Emphysema 2 2
Hematoma 2 2
Sepsis 2 2
Air Embolism 2 2
Patient Problem/Medical Problem 2 2
Septic Shock 1 1
Vomiting 1 1
Unspecified Eye / Vision Problem 1 1
Oversedation 1 1
Laceration(s) 1 1
Confusion/ Disorientation 1 1
Asthma 1 1
Swelling/ Edema 1 1
Shaking/Tremors 1 1
Pleural Empyema 1 1
No Information 1 1
Bronchial Hemorrhage 1 1
Unspecified Respiratory Problem 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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