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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
2018 15 15
2019 22 22
2020 54 54
2021 47 47
2022 109 109
2023 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 115 115
Break 75 75
Smoking 11 11
Detachment of Device or Device Component 11 11
Sparking 10 10
Device-Device Incompatibility 9 9
Mechanical Problem 8 8
Moisture Damage 8 8
Difficult to Open or Close 8 8
Unintended Movement 8 8
Thermal Decomposition of Device 7 7
Use of Device Problem 7 7
Loss of Power 7 7
Material Deformation 6 6
Device Damaged Prior to Use 5 5
Melted 5 5
Overheating of Device 4 4
Corroded 4 4
Crack 4 4
Degraded 4 4
Poor Quality Image 4 4
Device Emits Odor 4 4
Fire 4 4
Mechanical Jam 4 4
Device Contaminated During Manufacture or Shipping 4 4
Scratched Material 4 4
Device Fell 4 4
Temperature Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Electrical /Electronic Property Problem 3 3
Unintended Collision 3 3
Disconnection 3 3
Defective Component 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Difficult to Advance 2 2
Loose or Intermittent Connection 2 2
Misassembled 2 2
Detachment Of Device Component 2 2
Fracture 2 2
Electrical Power Problem 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Device Contamination with Chemical or Other Material 2 2
Complete Loss of Power 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Misassembly During Maintenance/Repair 1 1
Physical Resistance/Sticking 1 1
Misassembly by Users 1 1
Electrical Shorting 1 1
Environmental Particulates 1 1
Optical Problem 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Component Incompatible 1 1
No Display/Image 1 1
Component Missing 1 1
Arcing 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
No Information 30 30
No Consequences Or Impact To Patient 28 28
No Known Impact Or Consequence To Patient 22 22
No Patient Involvement 18 18
Insufficient Information 7 7
Injury 6 6
Not Applicable 4 4
Unspecified Tissue Injury 4 4
Bruise/Contusion 3 3
Patient Problem/Medical Problem 2 2
Electric Shock 2 2
Swelling/ Edema 1 1
No Code Available 1 1
Hyperextension 1 1
Laceration(s) 1 1
Pain 1 1
Shock 1 1
Sprain 1 1
Numbness 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jul-17-2019
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