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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device image, illumination, fiberoptic, for endoscope
Product CodeFFS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2014 5 5
2015 4 4
2016 7 7
2017 19 19
2018 19 19
2019 17 17
2020 56 56
2021 57 57
2022 10 10
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 63 63
Failure to Power Up 56 56
Protective Measures Problem 16 16
Unexpected Shutdown 15 15
Insufficient Information 10 10
Power Problem 9 9
Loss of Power 7 7
Smoking 6 6
Device Displays Incorrect Message 5 5
Noise, Audible 4 4
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
Electrical Shorting 3 3
Device Operates Differently Than Expected 3 3
Inadequate Lighting 3 3
Melted 3 3
Device Inoperable 3 3
Break 2 2
No Display/Image 2 2
Fire 2 2
Defective Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Electrical /Electronic Property Problem 2 2
Sparking 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
Electrical Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Scratched Material 1 1
Use of Device Problem 1 1
Optical Obstruction 1 1
Loose or Intermittent Connection 1 1
Device Issue 1 1
Hole In Material 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
No Known Impact Or Consequence To Patient 56 56
No Patient Involvement 33 33
No Information 9 9
No Consequences Or Impact To Patient 9 9
Full thickness (Third Degree) Burn 3 3
No Code Available 1 1
Burn, Thermal 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Blurred Vision 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Jun-05-2017
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