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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
Product CodeKQT
Regulation Number 876.4370
Device Class 2

MDR Year MDR Reports MDR Events
2018 10 10
2019 4 4
2020 16 16
2021 11 11
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 7 7
Fluid/Blood Leak 5 5
Device Contaminated During Manufacture or Shipping 5 5
Fitting Problem 4 4
Detachment of Device or Device Component 3 3
Device Contamination with Chemical or Other Material 3 3
Appropriate Term/Code Not Available 3 3
Leak/Splash 3 3
Filling Problem 3 3
Break 3 3
Decrease in Suction 2 2
Loose or Intermittent Connection 2 2
Material Fragmentation 2 2
Component Misassembled 2 2
Material Split, Cut or Torn 2 2
Material Discolored 2 2
Naturally Worn 1 1
Packaging Problem 1 1
Device Operates Differently Than Expected 1 1
Component Missing 1 1
Contamination /Decontamination Problem 1 1
Suction Failure 1 1
Missing Information 1 1
Inadequate Instructions for Healthcare Professional 1 1
Fracture 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Suction Problem 1 1
Degraded 1 1
Contamination 1 1
Air Leak 1 1
Inability to Auto-Fill 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 18 18
No Patient Involvement 5 5
Needle Stick/Puncture 1 1

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