Aquamantys™ 23-112-1 (UDI 00763000337063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000337063), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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 9, 2020Premature Activation; Premature Activation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE WAS ACTIVATING ON ITS OWN WITHOUT THE BUTTON BEING PUSHED. THERE WAS NO PATIENT HARM. THE SITE WAS FINISHED WITH THE HANDPIECE, SO A NEW ONE DID NOT NEED TO BE OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659651 ↗