• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
  1.  K211882  HD-550 Video Endoscope System
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 823 823
2021 1453 1453
2022 1828 1828
2023 2182 2182
2024 2648 2649
2025 250 250

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 2502 2503
Electrical /Electronic Property Problem 1097 1097
No Display/Image 837 837
Output Problem 552 552
Failure to Power Up 547 547
Poor Quality Image 508 508
No Device Output 429 429
Display or Visual Feedback Problem 357 357
No Visual Prompts/Feedback 334 334
Break 324 324
Power Problem 213 213
Connection Problem 200 200
Defective Component 172 172
Erratic or Intermittent Display 163 163
Optical Problem 153 153
Image Display Error/Artifact 119 119
Key or Button Unresponsive/not Working 106 106
Mechanical Problem 94 94
Loose or Intermittent Connection 90 90
Leak/Splash 81 81
Loss of Power 66 66
Overheating of Device 62 62
Intermittent Loss of Power 61 61
Defective Device 55 55
Detachment of Device or Device Component 51 51
Electrical Power Problem 48 48
Physical Resistance/Sticking 42 42
Unexpected Shutdown 38 38
Temperature Problem 33 33
Corroded 33 33
Noise, Audible 30 30
Crack 29 29
Fluid/Blood Leak 28 28
Energy Output Problem 23 23
Mechanical Jam 21 21
Flare or Flash 21 21
Material Integrity Problem 21 21
Material Split, Cut or Torn 20 20
Fracture 20 20
Intermittent Communication Failure 19 19
Failure to Clean Adequately 19 19
Application Program Problem 19 19
Activation Problem 18 18
Activation Failure 17 17
Use of Device Problem 17 17
Device Alarm System 17 17
Component Missing 17 17
Appropriate Term/Code Not Available 16 16
Dent in Material 15 15
Moisture Damage 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8112 8113
No Consequences Or Impact To Patient 737 737
No Patient Involvement 296 296
No Known Impact Or Consequence To Patient 31 31
Foreign Body In Patient 21 21
Insufficient Information 12 12
Burn(s) 9 9
Perforation 9 9
Unspecified Tissue Injury 5 5
Fever 4 4
Dysuria 4 4
Urinary Tract Infection 4 4
Patient Problem/Medical Problem 4 4
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Electric Shock 3 3
Perforation of Esophagus 2 2
Aspiration/Inhalation 2 2
Injury 2 2
No Information 2 2
Cough 2 2
Hemorrhage/Bleeding 2 2
Adult Respiratory Distress Syndrome 2 2
Superficial (First Degree) Burn 2 2
Partial thickness (Second Degree) Burn 2 2
Airway Obstruction 2 2
Bowel Perforation 1 1
Pain 1 1
Abdominal Pain 1 1
Abdominal Distention 1 1
Arrhythmia 1 1
Discomfort 1 1
Unspecified Hepatic or Biliary Problem 1 1
Rupture 1 1
Full thickness (Third Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Burn, Thermal 1 1
Sepsis 1 1
Blister 1 1
Bowel 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 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
-
-