SERFAS Energy 0279351103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327056976), received between May 29, 2018 and Jul 10, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING THE HIP JOINT SURGERY, THE METAL TIP OF THE RADIOFREQUENCY ABLATION ELECTRODE FELL INTO THE PATIENT'S BODY. THE DOCTOR SPENT ABOUT TWO HOURS SEARCHING UNDER THE MICROSCOPE DURING THE SURGERY, BUT FAILED. AFTERWARDS, AN INCISION WAS MADE TO SEARCH, BUT IT WAS STILL NOT FOUND. THE ELECTRODE PATCH IS EMBEDDED IN THE BODY AND CANNOT BE REMOVED

  Patient problems: Foreign Body In Patient

  MAUDE report 25784030 ↗
• MalfunctionOct 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457566 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED.

  Patient problems: No Code Available

  MAUDE report 7903059 ↗
• MalfunctionMay 29, 2018Break

  IT WAS REPORTED THAT THE RESIDUAL GLUE BROKE OFF DURING SURGERY. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7550887 ↗