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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device knife, surgical
Product CodeEMF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 6 6
2021 4 126
2022 10 132
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 141
Material Fragmentation 3 3
Material Separation 1 1
Component Missing 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 123
Unintended Movement 1 1
Device Handling Problem 1 1
Device Fell 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 133
Foreign Body In Patient 5 127
No Consequences Or Impact To Patient 4 4
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Abrasion 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Jun-18-2020
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