Aquamantys ™ 23-112-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169868168), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Arcing of Electrodes” (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.

• MalfunctionSep 22, 2020No Device Output; Arcing of Electrodes; No Device Output; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHILE BEING USED IN A PROCEDURE AN AEX HANDPIECE PRODUCED AN ELECTRICAL ARC AND THE GENERATOR DISPLAYED AN E1 DEVICE ERROR. THE GENERATOR WAS REBOOTED WITH THE HANDPIECE STILL CONNECTED AND ERROR PERSISTED. THE HANDOIECE WAS UNPLUGGED AND THE SURGERY RESUMED. THE SITE DID NOT HAVE ANOTHER HANDPIECE AVAILABLE AND PROCEEDED WITHOUT THE USE OF THE GENERATOR. THERE WAS A 5-10-MINUTE DELAY. THE SURGERY WAS RESUMED WITHOUT PATIENT HARM. IT WAS NOTED THAT THE GENERATOR DID NOT GIVE THE E1 HANDPIECE ERROR UNTIL THE HANDPIECE WAS PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10565687 ↗