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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 232 232
Detachment of Device or Device Component 52 52
Crack 19 19
Material Twisted/Bent 18 18
Contamination 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Mechanical Problem 11 11
Fracture 11 11
Thermal Decomposition of Device 9 9
Poor Quality Image 8 8
Material Integrity Problem 8 8
Material Deformation 7 7
Melted 6 6
Physical Resistance/Sticking 6 6
Optical Problem 6 6
Loose or Intermittent Connection 5 5
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
Component Missing 5 5
Mechanical Jam 4 4
Dent in Material 4 4
Sparking 3 3
Material Separation 3 3
Scratched Material 3 3
Material Fragmentation 3 3
Failure to Seal 2 2
Electrical /Electronic Property Problem 2 3
Corroded 2 2
Degraded 2 2
Difficult to Fold, Unfold or Collapse 2 2
Device Markings/Labelling Problem 2 2
Image Display Error/Artifact 2 2
No Display/Image 2 2
Material Frayed 2 2
Optical Distortion 1 1
Failure to Clean Adequately 1 1
Failure to Align 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Unintended Movement 1 1
Pitted 1 1
Material Disintegration 1 1
Device Handling Problem 1 1
Peeled/Delaminated 1 1
Activation Problem 1 1
Activation Failure 1 1
Output Problem 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 397 397
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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