Aquamantys(TM) 23-113-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000047436), received between Apr 18, 2019 and Apr 18, 2019 — 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.

• MalfunctionApr 18, 2019Premature Activation; Arcing of Electrodes; Premature Activation; Arcing of Electrodes

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE HANDPIECE WAS AVAILABLE FOR RETURN. THE REP NOTED THE SALINE WAS PRIMED. THE HCP NOTED THAT IT WAS ACTIVATING BEFORE EVEN PUSHING THE BUTTON. THE DEVICE WAS NEVER ACTIVATED ON THE PATIENT AND IT WAS RIGHT BEFORE THE CASE BEGAN. IT WAS NOTED A NEW HANDPIECE WAS OPENED AND HAD NO ISSUES. THE REP NOTED THE INFORMATION WAS CONFIRMED WITH THE ACCOUNT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529378 ↗