n.a. 24515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551263747), received between Mar 26, 2025 and Jan 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE VAAFT PROCEDURE, ELECTRODE TIP BROKE AWAY FROM THE INSULATION SHEATH. DIDN'T COMPLETELY BREAK OFF DUE TO THE WIRING, CAME OFF WHEN SCRUB WAS CLEANING IT. SURGEON WASN'T HAPPY TO CARRY ON SO WE GOT A SPARE ELECTRODE. PROCEDURE COMPLETED WITH LESS THAN 15 MINUTES DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094866 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THE SURGEON WAS USING THE PRODUCT DURING AN EPSIT PROCEDURE. THE SCRUB NURSE AND CONSULTANT ASKED MID CASE IF THE COAGULATION END SHOULD COME AWAY FROM THE INSULATION. IT WAS SAID NO AND ADVISED TO OPEN ANOTHER SET TO USE A SECOND ELECTRODE, BUT SURGEON DIDN'T THINK IT WAS WORTH OPENING A NEW SET FOR. THE CASE WAS FINISHED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704069 ↗