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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, cautery, radiofrequency, ac-powered
Regulation Description Radiofrequency electrosurgical cautery apparatus.
Product CodeHQR
Regulation Number 886.4100
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 1 1
Product Quality Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Capsular Bag Tear 2 2
Corneal Clouding/Hazing 1 1
Corneal Endothelial Cell Loss 1 1

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