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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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 168 168
Break 122 122
Sparking 24 24
Smoking 17 17
Moisture Damage 17 17
Detachment of Device or Device Component 17 17
Device-Device Incompatibility 14 14
Thermal Decomposition of Device 12 12
Mechanical Problem 12 12
Use of Device Problem 11 11
Loss of Power 10 10
Unintended Movement 10 10
Difficult to Open or Close 9 9
Device Contaminated During Manufacture or Shipping 9 9
Fire 9 9
Melted 8 8
Detachment Of Device Component 6 6
Device Operational Issue 6 6
Material Deformation 6 6
Device Fell 5 5
Degraded 5 5
Poor Quality Image 5 5
Device Emits Odor 5 5
Device Damaged Prior to Use 5 5
Loose or Intermittent Connection 4 4
Overheating of Device 4 4
Failure to Power Up 4 4
Electrical /Electronic Property Problem 4 4
Corroded 4 4
Crack 4 4
Scratched Material 4 4
Mechanical Jam 4 4
Device Operates Differently Than Expected 4 4
Electrical Power Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Temperature Problem 3 3
Disconnection 3 3
Unintended Collision 3 3
Defective Component 3 3
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Misassembled 2 2
Fracture 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Difficult or Delayed Separation 2 2
Power Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Difficult to Advance 2 2
Electrical Shorting 1 1
Environmental Particulates 1 1
Optical Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Misassembly During Maintenance/Repair 1 1
Complete Loss of Power 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Data Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Misassembly by Users 1 1
Material Fragmentation 1 1
No Display/Image 1 1
Component Falling 1 1
Component Incompatible 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1
Component Missing 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 303 303
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
Sprain 1 1
Swelling 1 1
Bowel Perforation 1 1
Burn(s) 1 1
Laceration(s) 1 1
Pain 1 1
Numbness 1 1
Burn, Thermal 1 1
Swelling/ Edema 1 1
No Code Available 1 1
Hyperextension 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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