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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscope maintenance system
Definition To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
Product CodePUP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 4 4
2023 1 1
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 7 7
Insufficient Information 5 5
Break 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 7 7
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Abrasion 1 1

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