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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ablation system, high intensity focused ultrasound (hifu), mr-guided
Definition An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.
Product CodeNRZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 2 2 3 5 1 2 5 0 3 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 3 3
2015 1 1
2017 2 2
2019 3 3
2022 2 2
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 3 3
Burn, Thermal 3 3
Bowel Perforation 3 3
Partial thickness (Second Degree) Burn 2 2
Abdominal Pain 2 2
Peritonitis 2 2
Death 1 1
Inflammation 1 1
Full thickness (Third Degree) Burn 1 1
Peripheral Nervous Injury 1 1

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