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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000047412), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionDec 14, 2021No Device Output; Device Damaged Prior to Use; No Device Output; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT FOR A COLUMN ARTHRODESIS PROCEDURE, WHEN OPENING THE MATERIAL OF A HANDPIECE FROM THE FIRST PACKAGE (PLASTIC) WAS SEALED. THE BOX CLOSED, WHEN REMOVING THE PACKAGING THAT CONTAINED THE BIPOLAR, IT WAS OPENED AND THE EQUIPMENT (WHICH PART OF THE BIPOLAR HAD AN IV IN ITS EXTENSION). THE INSTRUCTOR DID NOT TAKE THE TWEEZERS BECAUSE THE FIRST IMPRESSION WAS THAT HAD BEEN USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002883 ↗