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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscope, ac-powered and accessories
Product CodeGCP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2015 4 4
2016 13 13
2017 117 117
2018 26 26
2019 19 19
2020 18 18
2021 12 12
2022 26 26
2023 100 100
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 215 215
Detachment Of Device Component 35 35
Detachment of Device or Device Component 30 30
Product Quality Problem 23 23
Mechanical Problem 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Component Falling 19 19
Fracture 19 19
Material Fragmentation 18 18
Thermal Decomposition of Device 8 8
Contamination 7 7
Difficult to Open or Close 7 7
Material Twisted/Bent 7 7
Component Missing 6 6
Crack 5 5
Obstruction of Flow 5 5
Sparking 4 4
Nonstandard Device 4 4
Material Deformation 3 3
Physical Resistance/Sticking 3 3
Mechanical Jam 2 2
Device Handling Problem 2 2
Device Or Device Fragments Location Unknown 2 2
Optical Problem 2 2
Scratched Material 2 2
Device Operates Differently Than Expected 2 2
Melted 2 2
Poor Quality Image 2 2
Difficult to Remove 2 2
Material Separation 2 2
Material Disintegration 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Frayed 2 2
Image Display Error/Artifact 2 2
Bent 1 1
Charred 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Fire 1 1
Flaked 1 1
Corroded 1 1
Sticking 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Retraction Problem 1 1
Out-Of-Box Failure 1 1
Failure to Transmit Record 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Pitted 1 1
Difficult to Advance 1 1
Communication or Transmission Problem 1 1
Failure to Align 1 1
Failure to Form Staple 1 1
Arcing 1 1
No Apparent Adverse Event 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Failure to Clean Adequately 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
No Consequences Or Impact To Patient 81 81
Foreign Body In Patient 39 39
No Known Impact Or Consequence To Patient 37 37
Bacterial Infection 27 27
Device Embedded In Tissue or Plaque 6 6
Injury 4 4
Burn(s) 4 4
Hemorrhage/Bleeding 3 3
Internal Organ Perforation 2 2
Tissue Damage 2 2
No Code Available 2 2
Rupture 2 2
Urinary Incontinence 2 2
Insufficient Information 2 2
Hyponatremia 1 1
Urethral Stenosis/Stricture 1 1
Burn, Thermal 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Uterine Perforation 1 1
Perforation 1 1
Shock 1 1
Incontinence 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-23-2018
2 Olympus Corporation of the Americas II Jun-26-2017
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