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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 792 793

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 1955 1956
Electrical /Electronic Property Problem 1078 1078
No Display/Image 557 557
Failure to Power Up 455 455
Output Problem 364 364
Display or Visual Feedback Problem 312 312
No Device Output 267 267
Break 251 251
Poor Quality Image 232 232
Power Problem 193 193
No Visual Prompts/Feedback 182 182
Connection Problem 171 171
Defective Component 154 154
Optical Problem 130 130
Erratic or Intermittent Display 115 115
Image Display Error/Artifact 101 101
Key or Button Unresponsive/not Working 94 94
Mechanical Problem 83 83
Loss of Power 59 59
Loose or Intermittent Connection 54 54
Defective Device 52 52
Overheating of Device 51 51
Leak/Splash 50 50
Intermittent Loss of Power 50 50
Detachment of Device or Device Component 43 43
Electrical Power Problem 42 42
Unexpected Shutdown 35 35
Physical Resistance/Sticking 34 34
Temperature Problem 29 29
Noise, Audible 27 27
Fluid/Blood Leak 27 27
Corroded 26 26
Energy Output Problem 20 20
Application Program Problem 19 19
Flare or Flash 18 18
Mechanical Jam 18 18
Crack 18 18
Intermittent Communication Failure 18 18
Device Alarm System 16 16
Material Integrity Problem 16 16
Use of Device Problem 15 15
Failure to Clean Adequately 15 15
Appropriate Term/Code Not Available 15 15
Component Missing 14 14
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
Moisture or Humidity Problem 9 9
Contamination /Decontamination Problem 9 9
Sparking 8 8
Thermal Decomposition of Device 8 8
Display Difficult to Read 7 7
Fracture 7 7
Component or Accessory Incompatibility 7 7
Naturally Worn 7 7
Device Contamination with Chemical or Other Material 6 6
Electrical Shorting 6 6
Material Deformation 5 5
Misconnection 5 5
Degraded 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
Intermittent Continuity 4 4
Device Reprocessing Problem 4 4
Component Incompatible 4 4
Accessory Incompatible 4 4
Inflation Problem 4 4
Pressure Problem 4 4
Gas/Air Leak 4 4
Infusion or Flow Problem 4 4
Failure to Shut Off 3 3
Material Twisted/Bent 3 3
Operating System Becomes Nonfunctional 3 3
Device Sensing Problem 3 3
Device Markings/Labelling Problem 3 3
Device Emits Odor 3 3
Peeled/Delaminated 3 3
Disconnection 3 3
Emergency Power Failure 3 3
Entrapment of Device 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 6016 6017
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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