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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
Regulation Description Endoscope and accessories.
Product CodeGCP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 26 26
2023 100 100
2024 108 109
2025 182 182
2026 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Break 244 244
Detachment of Device or Device Component 59 59
Crack 20 20
Material Twisted/Bent 18 18
Fracture 13 13
Contamination 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Mechanical Problem 11 11
Loose or Intermittent Connection 9 9
Thermal Decomposition of Device 9 9
Poor Quality Image 8 8
Material Integrity Problem 8 8
Unstable 7 7
Material Deformation 7 7
Difficult to Open or Close 6 6
Melted 6 6
Physical Resistance/Sticking 6 6
Optical Problem 6 6
Device Reprocessing Problem 5 5
Labelling, Instructions for Use or Training Problem 5 5
Obstruction of Flow 5 5
Component Missing 5 5
Mechanical Jam 4 4
Corroded 4 4
Material Separation 4 4
Dent in Material 4 4
Material Fragmentation 4 4
Degraded 4 4
Scratched Material 3 3
Sparking 3 3
Difficult to Fold, Unfold or Collapse 2 2
Device Markings/Labelling Problem 2 2
Peeled/Delaminated 2 2
Image Display Error/Artifact 2 2
No Display/Image 2 2
Material Split, Cut or Torn 2 2
Electrical /Electronic Property Problem 2 3
Material Frayed 2 2
Failure to Seal 2 2
Optical Distortion 1 1
Failure to Clean Adequately 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Unintended Movement 1 1
Failure to Align 1 1
Material Disintegration 1 1
Complete Blockage 1 1
Pitted 1 1
Device Handling Problem 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 434 434
Foreign Body In Patient 13 13
Burn(s) 7 7
Sepsis 5 5
Urinary Tract Infection 5 5
Urethral Stenosis/Stricture 3 3
Urinary Incontinence 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Internal Organ Perforation 2 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hyponatremia 1 1
Perforation 1 1
Rupture 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-20-2026
2 Olympus Corporation of the Americas II Feb-20-2026
3 Olympus Corporation of the Americas II Nov-08-2024
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