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TPLC
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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 Code
ODB
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
GI SCIENTIFIC LLC
SUBSTANTIALLY EQUIVALENT
1
1. K183171
ScopeSeal Duodenoscope Protective Device
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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