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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic video imaging system/component, gastroenterology-urology
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product CodeFET
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJINON, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SCHOELLY IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
STI MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 25 25
2017 66 66
2018 67 67
2019 72 72
2020 3043 3043
2021 5300 5300
2022 6156 6156
2023 8199 8199
2024 9158 9158

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 15677 15677
Communication or Transmission Problem 4046 4046
Poor Quality Image 3793 3793
Erratic or Intermittent Display 1567 1567
Electrical /Electronic Property Problem 1103 1103
Failure to Power Up 1101 1101
Break 905 905
Display or Visual Feedback Problem 712 712
Output Problem 644 644
Connection Problem 626 626
Image Display Error/Artifact 490 490
Material Split, Cut or Torn 484 484
Loose or Intermittent Connection 413 413
Leak/Splash 404 404
Power Problem 393 393
Defective Component 317 317
Corroded 288 288
No Device Output 246 246
Crack 232 232
Gas/Air Leak 207 207
Detachment of Device or Device Component 181 181
Loss of Power 170 170
Disconnection 138 138
Key or Button Unresponsive/not Working 132 132
Mechanical Problem 126 126
Circuit Failure 112 112
Material Twisted/Bent 102 102
Intermittent Loss of Power 89 89
Image Orientation Incorrect 84 84
Material Integrity Problem 72 72
Defective Device 71 71
No Visual Prompts/Feedback 70 70
Optical Problem 68 68
Fluid/Blood Leak 65 65
Unexpected Shutdown 64 64
Material Puncture/Hole 62 62
Device Reprocessing Problem 60 60
Noise, Audible 51 51
Physical Resistance/Sticking 51 51
Signal Artifact/Noise 49 49
Material Deformation 49 49
Scratched Material 46 46
Application Program Problem 43 43
Fracture 42 42
Device Alarm System 38 38
Contamination 35 35
Electrical Power Problem 35 35
Adverse Event Without Identified Device or Use Problem 33 33
Failure to Clean Adequately 32 32
Misfocusing 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28206 28206
No Consequences Or Impact To Patient 2620 2620
No Patient Involvement 1079 1079
No Known Impact Or Consequence To Patient 241 241
Insufficient Information 51 51
Hemorrhage/Bleeding 18 18
No Information 14 14
Perforation 10 10
Patient Problem/Medical Problem 9 9
Burn(s) 7 7
Superficial (First Degree) Burn 6 6
No Code Available 6 6
Bowel Perforation 6 6
Pain 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Injury 4 4
Pancreatitis 4 4
Laceration(s) 4 4
Pneumothorax 4 4
Apnea 3 3
Burn, Thermal 3 3
Electric Shock 3 3
Blood Loss 3 3
Easy Bruising 2 2
Death 2 2
Foreign Body In Patient 2 2
Oversedation 1 1
Low Blood Pressure/ Hypotension 1 1
Discomfort 1 1
Urinary Tract Infection 1 1
Ischemia 1 1
Inflammation 1 1
Full thickness (Third Degree) Burn 1 1
Unspecified Tissue Injury 1 1
Emotional Changes 1 1
Unspecified Hepatic or Biliary Problem 1 1
Tissue Breakdown 1 1
Abdominal Pain 1 1
Unspecified Respiratory Problem 1 1
Arrhythmia 1 1
Post Operative Wound Infection 1 1
Bacterial Infection 1 1
Burning Sensation 1 1
Headache 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Fujifilm Medical Systems U.S.A., Inc. II Sep-22-2015
3 Karl Storz Endoscopy II Jul-06-2016
4 Olympus Corporation of the Americas II Jun-21-2018
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