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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
Regulation Description Endoscope and accessories.
Product CodeFFS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2016 7 7
2017 19 19
2018 19 19
2019 17 17
2020 56 56
2021 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 53 53
Overheating of Device 52 52
Protective Measures Problem 15 15
Unexpected Shutdown 11 11
Power Problem 9 9
Insufficient Information 8 8
Loss of Power 7 7
Noise, Audible 4 4
Device Displays Incorrect Message 4 4
Melted 3 3
Device Operates Differently Than Expected 3 3
Thermal Decomposition of Device 3 3
Electrical Shorting 3 3
Device Emits Odor 2 2
Break 2 2
Device Inoperable 2 2
Defective Component 2 2
Inadequate Lighting 2 2
No Display/Image 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Electrical Power Problem 1 1
Optical Obstruction 1 1
Fire 1 1
Sparking 1 1
No Device Output 1 1
Scratched Material 1 1
Device Issue 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
No Known Impact Or Consequence To Patient 50 50
No Patient Involvement 33 33
No Information 8 8
No Consequences Or Impact To Patient 7 7
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Blurred Vision 1 1
Burn, Thermal 1 1

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