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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device evacuator, gastro-urology
Regulation Description Gastroenterology-urology evacuator.
Product CodeKQT
Regulation Number 876.4370
Device Class 2

MDR Year MDR Reports MDR Events
2021 11 11
2022 8 8
2023 4 4
2024 6 6
2025 12 12
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6 6
Device Contaminated During Manufacture or Shipping 6 6
Disconnection 5 5
Fitting Problem 5 5
Material Fragmentation 4 4
Device Contamination with Chemical or Other Material 3 3
Material Split, Cut or Torn 2 2
Decrease in Suction 2 2
Component Misassembled 2 2
Patient Device Interaction Problem 1 1
Fracture 1 1
Break 1 1
Component Missing 1 1
Wrong Label 1 1
Missing Information 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 3 3
Unspecified Tissue Injury 1 1
Needle Stick/Puncture 1 1
Tissue Breakdown 1 1
No Consequences Or Impact To Patient 1 1
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jul-10-2026
2 Olympus Corporation of the Americas II Jul-21-2025
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