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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
Regulation Description Endoscope and accessories.
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 2

MDR Year MDR Reports MDR Events
2021 1453 1461
2022 1828 1832
2023 2180 2182
2024 2648 2653
2025 2888 2888

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 3080 3083
No Display/Image 1156 1159
Electrical /Electronic Property Problem 956 957
Poor Quality Image 805 807
Output Problem 729 729
No Device Output 567 567
Failure to Power Up 523 523
No Visual Prompts/Feedback 393 393
Display or Visual Feedback Problem 371 371
Break 357 357
Connection Problem 234 237
Erratic or Intermittent Display 205 206
Power Problem 202 202
Activation Failure 175 175
Defective Component 164 164
Optical Problem 162 162
Key or Button Unresponsive/not Working 136 136
Leak/Splash 134 134
Image Display Error/Artifact 107 107
Mechanical Problem 102 103
Loose or Intermittent Connection 101 101
Failure to Clean Adequately 71 71
Intermittent Loss of Power 68 68
Overheating of Device 64 64
Activation Problem 61 61
Loss of Power 61 61
Detachment of Device or Device Component 61 61
Physical Resistance/Sticking 60 60
Corroded 53 53
Unexpected Shutdown 46 46
Dent in Material 46 46
Crack 45 45
Electrical Power Problem 43 43
Material Integrity Problem 40 40
Material Split, Cut or Torn 37 37
Defective Device 35 35
Noise, Audible 34 34
Contamination 32 32
Intermittent Communication Failure 32 32
Mechanical Jam 30 30
Temperature Problem 30 30
Environmental Particulates 30 30
Fracture 29 29
Fluid/Blood Leak 29 29
Degraded 28 28
Flare or Flash 27 27
Moisture Damage 26 26
Device Alarm System 20 20
Energy Output Problem 18 18
Use of Device Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10726 10736
No Consequences Or Impact To Patient 187 187
No Patient Involvement 59 59
Foreign Body In Patient 24 29
Insufficient Information 21 24
Perforation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burn(s) 5 5
Unspecified Tissue Injury 5 5
Dysuria 4 4
Fever 4 4
Cough 4 4
Urinary Tract Infection 4 4
Airway Obstruction 3 3
Device Embedded In Tissue or Plaque 3 3
Superficial (First Degree) Burn 2 2
Adult Respiratory Distress Syndrome 2 2
Perforation of Esophagus 2 2
Aspiration/Inhalation 2 2
Partial thickness (Second Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Abdominal Pain 1 1
Patient Problem/Medical Problem 1 1
Arrhythmia 1 1
Sepsis 1 1
No Information 1 1
Rupture 1 1
Blister 1 1
Pain 1 1
Unspecified Hepatic or Biliary Problem 1 1
Asystole 1 1
Unspecified Respiratory Problem 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Olympus Corporation of the Americas II Jun-05-2025
3 Olympus Corporation of the Americas II Feb-29-2024
4 Olympus Corporation of the Americas I Nov-09-2023
5 Olympus Corporation of the Americas II Feb-13-2023
6 Olympus Corporation of the Americas II May-19-2022
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