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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
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 72 72
2020 3043 3043
2021 5300 5300
2022 6156 6156
2023 8199 8199
2024 2938 2938

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 13697 13697
Communication or Transmission Problem 3328 3328
Poor Quality Image 2386 2386
Erratic or Intermittent Display 1332 1332
Electrical /Electronic Property Problem 1075 1075
Failure to Power Up 954 954
Display or Visual Feedback Problem 628 628
Break 580 580
Connection Problem 488 488
Image Display Error/Artifact 442 442
Output Problem 437 437
Power Problem 374 374
Defective Component 294 294
Loose or Intermittent Connection 250 250
Material Split, Cut or Torn 181 181
Loss of Power 150 150
No Device Output 135 135
Key or Button Unresponsive/not Working 122 122
Detachment of Device or Device Component 109 109
Corroded 105 105
Circuit Failure 97 97
Material Twisted/Bent 95 95
Mechanical Problem 91 91
Leak/Splash 91 91
Crack 90 90
Intermittent Loss of Power 71 71
Defective Device 65 65
Image Orientation Incorrect 63 63
Disconnection 62 62
Optical Problem 57 57
Gas/Air Leak 49 49
Unexpected Shutdown 47 47
Physical Resistance/Sticking 46 46
Device Reprocessing Problem 44 44
Application Program Problem 43 43
No Visual Prompts/Feedback 42 42
Material Integrity Problem 40 40
Device Alarm System 38 38
Signal Artifact/Noise 38 38
Fluid/Blood Leak 38 38
Noise, Audible 38 38
Material Deformation 33 33
Electrical Power Problem 31 31
Adverse Event Without Identified Device or Use Problem 27 27
Fracture 25 25
Contamination 23 23
Material Puncture/Hole 21 21
Mechanical Jam 21 21
Electrical Shorting 20 20
Component Missing 20 20
Display Difficult to Read 20 20
Incomplete or Inadequate Connection 19 19
Failure to Clean Adequately 18 18
Complete Loss of Power 16 16
Use of Device Problem 16 16
Misfocusing 15 15
Intermittent Communication Failure 14 14
Misconnection 13 13
Sparking 12 12
Device Contamination with Chemical or Other Material 12 12
Optical Discoloration 12 12
Appropriate Term/Code Not Available 12 12
Scratched Material 12 12
Insufficient Information 11 11
Unintended Movement 10 10
Device Dislodged or Dislocated 10 10
Deformation Due to Compressive Stress 10 10
Overheating of Device 10 10
Degraded 10 10
Energy Output Problem 9 9
Naturally Worn 9 9
Device Fell 9 9
Protective Measures Problem 8 8
Flare or Flash 8 8
Moisture Damage 8 8
Material Fragmentation 7 7
Intermittent Capture 7 7
Contamination /Decontamination Problem 7 7
Device Damaged Prior to Use 7 7
Failure to Read Input Signal 7 7
Smoking 7 7
Problem with Sterilization 7 7
Poor Visibility 7 7
Device Sensing Problem 6 6
Optical Distortion 6 6
Component Incompatible 6 6
Computer Software Problem 5 5
Intermittent Continuity 5 5
Peeled/Delaminated 5 5
Blocked Connection 5 5
No Apparent Adverse Event 5 5
Activation Failure 5 5
Excessive Heating 5 5
Application Program Freezes, Becomes Nonfunctional 4 4
Output below Specifications 4 4
Temperature Problem 4 4
Activation Problem 4 4
Separation Problem 4 4
Battery Problem 4 4
Failure to Sense 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21998 21998
No Consequences Or Impact To Patient 2590 2590
No Patient Involvement 1079 1079
No Known Impact Or Consequence To Patient 127 127
Insufficient Information 40 40
Hemorrhage/Bleeding 17 17
No Information 13 13
Perforation 9 9
Patient Problem/Medical Problem 9 9
Superficial (First Degree) Burn 6 6
Pain 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burn(s) 4 4
Pancreatitis 4 4
Bowel Perforation 4 4
No Code Available 3 3
Apnea 3 3
Laceration(s) 3 3
Foreign Body In Patient 2 2
Electric Shock 2 2
Blood Loss 2 2
Injury 2 2
Easy Bruising 2 2
Unspecified Tissue Injury 1 1
Post Operative Wound Infection 1 1
Burn, Thermal 1 1
Discomfort 1 1
Tissue Breakdown 1 1
Unspecified Hepatic or Biliary Problem 1 1
Unspecified Respiratory Problem 1 1
Oversedation 1 1
Arrhythmia 1 1
Abdominal Pain 1 1
Pneumothorax 1 1
Burning Sensation 1 1
Death 1 1
Emotional Changes 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Ischemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
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