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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic contamination prevention sheath
Regulation Description Endoscope and accessories.
Definition To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Product CodeODB
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2022 2 2
2023 8 8
2024 2 2
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 10 10
Break 6 6
Material Fragmentation 4 4
Material Separation 4 4
Material Twisted/Bent 3 3
Mechanical Problem 2 2
Solder Joint Fracture 2 2
Loss of or Failure to Bond 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Foreign Body In Patient 8 8
Insufficient Information 5 5
Malaise 2 2
Discomfort 2 2
Distress 2 2
Unintended Radiation Exposure 2 2
Unspecified Kidney or Urinary Problem 1 1
Urinary Tract Infection 1 1

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