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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, photographic, for endoscope (exclude light sources)
Regulation Description Endoscope and accessories.
Product CodeFEM
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2021 47 47
2022 109 109
2023 131 132
2024 108 108
2025 119 119
2026 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 256 256
Break 153 154
Moisture Damage 41 41
Device-Device Incompatibility 35 35
Device Contaminated During Manufacture or Shipping 29 29
Detachment of Device or Device Component 21 21
Use of Device Problem 17 17
Unintended Movement 14 14
Difficult to Open or Close 12 12
Sparking 11 11
Degraded 11 11
Crack 10 10
Material Deformation 10 10
Smoking 10 10
Mechanical Jam 9 9
Fire 8 8
Temperature Problem 5 5
Scratched Material 5 5
Mechanical Problem 5 5
Failure to Power Up 4 4
Fracture 4 4
Loss of Power 4 4
Difficult to Advance 3 3
Thermal Decomposition of Device 3 3
Difficult or Delayed Separation 3 3
Electrical Shorting 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Electrical /Electronic Property Problem 3 3
Contamination /Decontamination Problem 2 2
Battery Problem 2 2
Insufficient Device Problem Information 2 2
Electrical Power Problem 2 2
Power Problem 2 2
Device Reprocessing Problem 2 2
Melted 2 2
Poor Quality Image 2 2
Unintended Collision 2 2
Material Integrity Problem 1 1
Defective Device 1 1
Microbial Contamination of Device 1 1
Defective Component 1 1
Device Fell 1 1
Material Fragmentation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Electrical Shock 1 1
Data Problem 1 1
Environmental Particulates 1 1
Connection Problem 1 1
Naturally Worn 1 1
Complete Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 544 545
Insufficient Information 7 7
Unspecified Tissue Injury 4 4
Electric Shock 3 3
Burn(s) 1 1
Numbness 1 1
Pain 1 1
Hyperextension 1 1
Swelling/ Edema 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Sep-22-2023
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