NA 0502990300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327064018), received between Oct 1, 2018 and Mar 4, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Overheating of Device; Material Separation

  IT WAS REPORTED THAT MONOPOLAR CORD STARTED ON FIRE DURING A CASE IN MORNING. THERE WAS PATIENT INVOLVEMENT BUT LUCKILY NO ONE WAS INJURED. AT THE END OF THE CASE, THE CIRCULATION NOTICED THE MONOPOLAR CORD HAD SPLIT AND ONE END WENT UP IN A SMALL FLAME (LIKE A LIGHTER). THEY WERE FINISHED AT THE POINT OF NOTICING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509195 ↗
• MalfunctionSep 29, 2022Electrical Shorting; Sparking; Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE SPARKED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501896 ↗
• InjuryOct 1, 2018Temperature Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE CORD DURING A PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 7924482 ↗