Aquamantys ™ 23-301-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169868205), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2019Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT DURING A PROCEDURE, THE SITE HEARD A LOUD SPARK AND WAS UNSURE IF IT CAME FROM THE HANDPIECES ATTACHED OR THE GENERATOR. THEY WERE USING A PLASMA BLADE AND AN AQUAMANTYS. THEY CONTINUED USING THE SAME PLASMABLADE, BUT SWITCHED TO ANOTHER AQUAMANTYS HANDPIECE WITH NO KNOWN ISSUES AFTER THAT. THERE WAS NO REPORTED DELAY AND NO IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THEY DID NOT HAVE THE PATIENT'S WEIGHT. IT WAS NOTED THE INFORMATION WAS CONFIRMED WITH THE ACCOUNT/PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191993 ↗