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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, sonic and accessory/attachment
Regulation Description Sonic surgical instrument and accessories/attachments.
Product CodeJDX
Regulation Number 888.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
SMTP TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 10 11
2023 5 5
2024 6 6
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 16 16
Break 7 7
Fracture 4 4
Mechanical Problem 3 3
Energy Output Problem 2 2
Entrapment of Device 2 2
Overheating of Device 1 2
Failure to Fire 1 1
Communication or Transmission Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Foreign Body In Patient 7 7
Insufficient Information 3 4
Oversedation 2 2
Discomfort 2 2
Pain 2 2
Device Embedded In Tissue or Plaque 1 1

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