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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
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 106 106
Moisture Damage 17 17
Detachment of Device or Device Component 16 16
Device-Device Incompatibility 14 14
Sparking 13 13
Smoking 12 12
Use of Device Problem 10 10
Unintended Movement 10 10
Device Contaminated During Manufacture or Shipping 9 9
Mechanical Problem 9 9
Difficult to Open or Close 9 9
Fire 9 9
Thermal Decomposition of Device 6 6
Loss of Power 6 6
Material Deformation 6 6
Device Fell 5 5
Melted 5 5
Degraded 5 5
Poor Quality Image 5 5
Device Emits Odor 4 4
Corroded 4 4
Crack 4 4
Device Damaged Prior to Use 4 4
Mechanical Jam 4 4
Overheating of Device 4 4
Scratched Material 4 4
Temperature Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Electrical Power Problem 3 3
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Electrical /Electronic Property Problem 3 3
Disconnection 2 2
Unintended Collision 2 2
Fracture 2 2
Defective Component 2 2
Failure to Power Up 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Advance 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Difficult or Delayed Separation 2 2
Power Problem 2 2
Misassembly During Maintenance/Repair 1 1
Data Problem 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Optical Problem 1 1
Misassembled 1 1
Component Missing 1 1
Arcing 1 1
Device Tipped Over 1 1
Electrical Shorting 1 1
Environmental Particulates 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 303 303
No Consequences Or Impact To Patient 25 25
No Information 20 20
No Patient Involvement 18 18
No Known Impact Or Consequence To Patient 14 14
Insufficient Information 7 7
Injury 6 6
Unspecified Tissue Injury 4 4
Not Applicable 3 3
Bruise/Contusion 3 3
Electric Shock 3 3
Patient Problem/Medical Problem 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
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 Corporation of the Americas II Jul-17-2019
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