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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
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 1025 1026

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 2023 2024
Electrical /Electronic Property Problem 1080 1080
No Display/Image 592 592
Failure to Power Up 472 472
Output Problem 379 379
Display or Visual Feedback Problem 316 316
No Device Output 285 285
Break 262 262
Poor Quality Image 256 256
No Visual Prompts/Feedback 197 197
Power Problem 194 194
Connection Problem 173 173
Defective Component 156 156
Optical Problem 131 131
Erratic or Intermittent Display 120 120
Image Display Error/Artifact 103 103
Key or Button Unresponsive/not Working 95 95
Mechanical Problem 84 84
Loss of Power 59 59
Loose or Intermittent Connection 55 55
Leak/Splash 54 54
Defective Device 53 53
Overheating of Device 52 52
Intermittent Loss of Power 50 50
Detachment of Device or Device Component 43 43
Electrical Power Problem 43 43
Unexpected Shutdown 35 35
Physical Resistance/Sticking 35 35
Temperature Problem 29 29
Noise, Audible 28 28
Fluid/Blood Leak 27 27
Corroded 27 27
Energy Output Problem 20 20
Crack 19 19
Flare or Flash 19 19
Application Program Problem 19 19
Mechanical Jam 18 18
Intermittent Communication Failure 18 18
Material Integrity Problem 17 17
Use of Device Problem 16 16
Device Alarm System 16 16
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
Insufficient Cooling 10 10
Circuit Failure 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
Material Deformation 6 6
Device Contamination with Chemical or Other Material 6 6
Electrical Shorting 6 6
Separation Problem 6 6
Material Split, Cut or Torn 6 6
Incomplete or Inadequate Connection 5 5
Air/Gas in Device 5 5
Poor Visibility 5 5
Misconnection 5 5
Degraded 5 5
Intermittent Continuity 5 5
Accessory Incompatible 4 4
Device Reprocessing Problem 4 4
Component Incompatible 4 4
Inflation Problem 4 4
Gas/Air Leak 4 4
Infusion or Flow Problem 4 4
Material Twisted/Bent 4 4
Unintended Movement 4 4
Pressure Problem 4 4
Protective Measures Problem 3 3
Complete Loss of Power 3 3
No Flow 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
Device Emits Odor 3 3
Peeled/Delaminated 3 3
Disconnection 3 3
Emergency Power Failure 3 3
Entrapment of Device 3 3
Electromagnetic Interference 2 2
Use of Incorrect Control/Treatment Settings 2 2
Signal Artifact/Noise 2 2
Failure to Reset 2 2
Fire 2 2
Material Fragmentation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6247 6248
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
Insufficient Information 10 10
Burn(s) 9 9
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
Hemorrhage/Bleeding 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
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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