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U.S. Department of Health and Human Services

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
OLYMPUS CORPORATION OF THE AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 22 22
2015 32 32
2016 25 25
2017 17 17
2018 4 4
2019 3 3
2020 823 823
2021 1453 1453
2022 1828 1828
2023 2182 2182
2024 1762 1763

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 2216 2217
Electrical /Electronic Property Problem 1086 1086
No Display/Image 677 677
Failure to Power Up 513 513
Output Problem 452 452
Poor Quality Image 357 357
No Device Output 345 345
Display or Visual Feedback Problem 332 332
Break 289 289
No Visual Prompts/Feedback 272 272
Power Problem 198 198
Connection Problem 184 184
Defective Component 162 162
Optical Problem 141 141
Erratic or Intermittent Display 136 136
Image Display Error/Artifact 111 111
Key or Button Unresponsive/not Working 99 99
Mechanical Problem 87 87
Loose or Intermittent Connection 68 68
Leak/Splash 68 68
Loss of Power 60 60
Overheating of Device 58 58
Defective Device 54 54
Intermittent Loss of Power 52 52
Detachment of Device or Device Component 48 48
Electrical Power Problem 45 45
Physical Resistance/Sticking 38 38
Unexpected Shutdown 37 37
Adverse Event Without Identified Device or Use Problem 31 31
Temperature Problem 31 31
Corroded 30 30
Noise, Audible 30 30
Fluid/Blood Leak 28 28
Crack 26 26
Energy Output Problem 20 20
Flare or Flash 20 20
Application Program Problem 19 19
Mechanical Jam 19 19
Intermittent Communication Failure 18 18
Material Integrity Problem 18 18
Appropriate Term/Code Not Available 18 18
Contamination /Decontamination Problem 18 18
Component Missing 18 18
Use of Device Problem 17 17
Device Alarm System 16 16
Contamination 16 16
Failure to Clean Adequately 16 16
Microbial Contamination of Device 15 15
Device Reprocessing Problem 13 13
Moisture Damage 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6982 6983
No Consequences Or Impact To Patient 761 761
No Patient Involvement 297 297
No Known Impact Or Consequence To Patient 47 47
Foreign Body In Patient 21 21
Insufficient Information 10 10
Fever 10 10
Burn(s) 10 10
Injury 9 9
Perforation 9 9
No Information 9 9
Unspecified Infection 8 8
Electric Shock 8 8
Bowel Perforation 7 7
Device Embedded In Tissue or Plaque 6 6
Bacterial Infection 6 6
Unspecified Tissue Injury 5 5
Urinary Tract Infection 5 5
Dysuria 4 4
Patient Problem/Medical Problem 4 4
Hemorrhage/Bleeding 4 4
Aspiration/Inhalation 3 3
Hematoma 3 3
Chemical Exposure 3 3
No Code Available 3 3
Pain 3 3
Abdominal Pain 3 3
Perforation of Esophagus 2 2
Abdominal Distention 2 2
Adult Respiratory Distress Syndrome 2 2
Vomiting 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pneumonia 2 2
Cough 2 2
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
Airway Obstruction 2 2
Inflammation 1 1
Bowel Burn 1 1
Rupture 1 1
Burn, Thermal 1 1
Blister 1 1
Sepsis 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Chest Pain 1 1
Diarrhea 1 1
Septic Shock 1 1
Cramp(s) 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
7 Olympus Corporation of the Americas II Feb-24-2017
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