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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
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


Premarket Reviews
ManufacturerDecision
GI SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 1
LUMENR, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 2 2
2019 6 6
2020 5 5
2022 2 2
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 13 13
Detachment of Device or Device Component 5 5
Material Fragmentation 5 5
Break 2 2
Material Twisted/Bent 2 2
Infusion or Flow Problem 1 1
Detachment Of Device Component 1 1
Fracture 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
Insufficient Information 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 3 3
Discomfort 2 2
Device Embedded In Tissue or Plaque 1 1
Urethral Stenosis/Stricture 1 1

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