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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
2019 19 19
2020 18 18
2021 12 12
2022 26 26
2023 100 100
2024 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
Break 129 129
Detachment of Device or Device Component 31 31
Adverse Event Without Identified Device or Use Problem 18 18
Contamination 12 12
Mechanical Problem 11 11
Fracture 11 11
Material Fragmentation 9 9
Crack 8 8
Material Twisted/Bent 8 8
Thermal Decomposition of Device 8 8
Difficult to Open or Close 5 5
Device Reprocessing Problem 5 5
Labelling, Instructions for Use or Training Problem 5 5
Obstruction of Flow 5 5
Material Deformation 5 5
Physical Resistance/Sticking 4 4
Poor Quality Image 4 4
Component Missing 4 4
Sparking 3 3
Loose or Intermittent Connection 3 3
Scratched Material 3 3
Material Frayed 2 2
Electrical /Electronic Property Problem 2 2
Image Display Error/Artifact 2 2
Material Disintegration 2 2
Difficult to Fold, Unfold or Collapse 2 2
Melted 2 2
Material Separation 2 2
Degraded 2 2
Optical Problem 2 2
Mechanical Jam 1 1
Arcing 1 1
Failure to Disinfect 1 1
Corroded 1 1
Failure to Form Staple 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Pitted 1 1
Dent in Material 1 1
Failure to Align 1 1
Use of Device Problem 1 1
Difficult to Remove 1 1
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Device Fell 1 1
Difficult to Advance 1 1
Unintended Electrical Shock 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 207 207
Foreign Body In Patient 12 12
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 10 10
Sepsis 5 5
Urinary Tract Infection 5 5
Bacterial Infection 4 4
Burn(s) 3 3
Device Embedded In Tissue or Plaque 3 3
Urethral Stenosis/Stricture 3 3
Urinary Incontinence 2 2
Insufficient Information 2 2
Tissue Damage 2 2
Rupture 2 2
Hemorrhage/Bleeding 2 2
Internal Organ Perforation 2 2
Perforation 1 1
Uterine Perforation 1 1
Shock 1 1
Burn, Thermal 1 1
Blood Loss 1 1
No Patient Involvement 1 1
No Code Available 1 1
Hyponatremia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Nov-08-2024
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