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TPLC - Total Product Life Cycle
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Device endoscope, accessories, narrow band spectrum
Definition Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Product CodeNWB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
SONOSCAPE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 823 823
2021 1453 1453
2022 1828 1828
2023 2182 2182
2024 562 563

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 1890 1891
Electrical /Electronic Property Problem 1077 1077
No Display/Image 519 519
Failure to Power Up 436 436
Output Problem 346 346
Display or Visual Feedback Problem 309 309
No Device Output 250 250
Break 247 247
Poor Quality Image 210 210
Power Problem 188 188
Connection Problem 169 169
No Visual Prompts/Feedback 166 166
Defective Component 153 153
Optical Problem 130 130
Erratic or Intermittent Display 110 110
Image Display Error/Artifact 99 99
Key or Button Unresponsive/not Working 91 91
Mechanical Problem 82 82
Loss of Power 58 58
Defective Device 52 52
Loose or Intermittent Connection 52 52
Overheating of Device 50 50
Leak/Splash 48 48
Intermittent Loss of Power 48 48
Detachment of Device or Device Component 42 42
Electrical Power Problem 42 42
Unexpected Shutdown 35 35
Physical Resistance/Sticking 34 34
Temperature Problem 28 28
Fluid/Blood Leak 27 27
Noise, Audible 26 26
Corroded 24 24
Energy Output Problem 20 20
Application Program Problem 19 19
Mechanical Jam 18 18
Crack 18 18
Flare or Flash 17 17
Intermittent Communication Failure 17 17
Material Integrity Problem 16 16
Device Alarm System 16 16
Use of Device Problem 15 15
Appropriate Term/Code Not Available 15 15
Failure to Clean Adequately 14 14
Component Missing 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Contamination 12 12
Output below Specifications 11 11
Smoking 11 11
Installation-Related Problem 10 10
Circuit Failure 10 10
Insufficient Cooling 10 10
Moisture Damage 10 10
Excessive Heating 10 10
Unintended Power Up 9 9
Contamination /Decontamination Problem 9 9
Moisture or Humidity Problem 8 8
Thermal Decomposition of Device 8 8
Fracture 7 7
Naturally Worn 7 7
Component or Accessory Incompatibility 7 7
Sparking 7 7
Electrical Shorting 6 6
Device Contamination with Chemical or Other Material 6 6
Display Difficult to Read 6 6
Degraded 5 5
Misconnection 5 5
Incomplete or Inadequate Connection 5 5
Separation Problem 5 5
Air/Gas in Device 5 5
Poor Visibility 5 5
Material Split, Cut or Torn 4 4
Unintended Movement 4 4
Inflation Problem 4 4
Intermittent Continuity 4 4
Device Reprocessing Problem 4 4
Component Incompatible 4 4
Accessory Incompatible 4 4
Gas/Air Leak 4 4
Infusion or Flow Problem 4 4
Material Deformation 4 4
Pressure Problem 4 4
Material Twisted/Bent 3 3
Operating System Becomes Nonfunctional 3 3
Failure to Shut Off 3 3
Device Sensing Problem 3 3
Device Markings/Labelling Problem 3 3
Disconnection 3 3
Emergency Power Failure 3 3
Entrapment of Device 3 3
Device Emits Odor 3 3
Peeled/Delaminated 3 3
Complete Loss of Power 3 3
Activation Problem 2 2
Intermittent Energy Output 2 2
Ventilation Problem in Device Environment 2 2
Misassembly by Users 2 2
Insufficient Information 2 2
Wireless Communication Problem 2 2
Device Handling Problem 2 2
Audible Prompt/Feedback Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5786 5787
No Consequences Or Impact To Patient 738 738
No Patient Involvement 296 296
No Known Impact Or Consequence To Patient 33 33
Foreign Body In Patient 19 19
Burn(s) 9 9
Insufficient Information 8 8
Perforation 7 7
Urinary Tract Infection 4 4
Fever 4 4
Patient Problem/Medical Problem 4 4
Dysuria 4 4
Unspecified Tissue Injury 4 4
Electric Shock 3 3
Device Embedded In Tissue or Plaque 3 3
No Information 2 2
Cough 2 2
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
Adult Respiratory Distress Syndrome 2 2
Airway Obstruction 2 2
Aspiration/Inhalation 2 2
Injury 2 2
Perforation of Esophagus 2 2
Burn, Thermal 1 1
Rupture 1 1
Discomfort 1 1
Abdominal Pain 1 1
Sepsis 1 1
Bowel Burn 1 1
Arrhythmia 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Respiratory Problem 1 1
Unspecified Hepatic or Biliary Problem 1 1
Blister 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Olympus Corporation of the Americas II Feb-29-2024
3 Olympus Corporation of the Americas I Nov-09-2023
4 Olympus Corporation of the Americas II Feb-13-2023
5 Olympus Corporation of the Americas II May-19-2022
6 Olympus Corporation of the Americas II Mar-12-2019
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