Aquamantys ™ 23-313-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169868250), received between Jul 2, 2021 and Jul 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Shut Off” (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.

• MalfunctionJul 2, 2021Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING SURGERY, THERE WAS A PROBLEM WITH THE HANDPIECE BUTTON, WHERE IT DID NOT STOP WORKING AND THE TWEEZERS REMAINED WORKING UNINTERRUPTEDLY, THE PRODUCT WARMED UP AND THE BUTTON DID NOT TURN OFF. IT WAS NECESSARY TO OPEN ANOTHER HANDPIECE TO SOLVE THE PROBLEM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109194 ↗