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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, clip forming/cutting
Product CodeHBS
Regulation Number 882.4190
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2020 1 1
2022 4 4
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 2 2
Excessive Heating 2 2
Connection Problem 1 1
Mechanical Jam 1 1
Device Alarm System 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Bone Fracture(s) 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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