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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)
Product CodeFEM
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 5 5
2016 9 9
2017 14 14
2018 15 15
2019 22 22
2020 54 54
2021 47 47
2022 109 109
2023 131 131
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 185 185
Break 135 135
Sparking 25 25
Moisture Damage 24 24
Detachment of Device or Device Component 21 21
Smoking 17 17
Device-Device Incompatibility 16 16
Thermal Decomposition of Device 12 12
Mechanical Problem 12 12
Use of Device Problem 11 11
Unintended Movement 11 11
Loss of Power 10 10
Fire 9 9
Difficult to Open or Close 9 9
Device Contaminated During Manufacture or Shipping 9 9
Degraded 8 8
Material Deformation 8 8
Melted 8 8
Failure to Power Up 6 6
Device Operational Issue 6 6
Detachment Of Device Component 6 6
Device Emits Odor 5 5
Device Fell 5 5
Poor Quality Image 5 5
Device Damaged Prior to Use 5 5
Scratched Material 4 4
Insufficient Information 4 4
Crack 4 4
Device Operates Differently Than Expected 4 4
Appropriate Term/Code Not Available 4 4
Overheating of Device 4 4
Electrical /Electronic Property Problem 4 4
Loose or Intermittent Connection 4 4
Corroded 4 4
Mechanical Jam 4 4
Defective Device 3 3
Defective Component 3 3
Electrical Power Problem 3 3
Disconnection 3 3
Unintended Collision 3 3
Temperature Problem 3 3
Difficult or Delayed Separation 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Contamination /Decontamination Problem 3 3
Lack of Maintenance Documentation or Guidelines 2 2
Power Problem 2 2
Fracture 2 2
Misassembled 2 2
Difficult to Advance 2 2
Battery Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 341 341
No Known Impact Or Consequence To Patient 38 38
No Consequences Or Impact To Patient 37 37
No Information 33 33
No Patient Involvement 20 20
Injury 7 7
Insufficient Information 7 7
Not Applicable 6 6
Unspecified Tissue Injury 4 4
Electric Shock 3 3
Bruise/Contusion 3 3
Patient Problem/Medical Problem 2 2
Shock 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Bowel Perforation 1 1
Sprain 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Swelling 1 1
Numbness 1 1
Laceration(s) 1 1
Pain 1 1
Hyperextension 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Sep-22-2023
2 Olympus America Inc. II Mar-05-2012
3 Olympus Corporation of the Americas II Jul-17-2019
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