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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
Regulation Description Endoscope and accessories.
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 8
2023 1 2
2024 11 16
2025 6 6
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 13 19
Insufficient Information 6 10
Detachment of Device or Device Component 3 4
Break 1 2
Entrapment of Device 1 2
Physical Resistance/Sticking 1 2
Device Contamination with Chemical or Other Material 1 2
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 12 17
No Clinical Signs, Symptoms or Conditions 5 7
Abrasion 2 3
No Known Impact Or Consequence To Patient 2 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Insufficient Information 1 1
Pain 1 1

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