Aquamantys® 40-402-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169078741), received between Jul 24, 2020 and Feb 13, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fire” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FORM HEALTHCARE PROVIDER REGARDING THE GENERATOR. IT WAS REPORTED THAT DURING A PREVENTIVE MAINTENANCE CHECK, THE OUTPUT VALUES OF THE GENERATOR WERE TOO HIGH WHEN TESTING AT 200 OHMS AND 200W. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372299 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT A HANDPIECE WAS USED FOR A PARTIAL LIVER RESECTION AND THE SITE BELIEVED THAT IT MAY BE ASSOCIATED WITH A BURN ON THE PATIENT. IT WAS NOTED THAT THE BOX FOR THE HANDPIECE WAS NOT SAVED. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 17257762 ↗
• MalfunctionMay 3, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING TWO GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE HANDPIECES WAS EXCESSIVELY SPARKING. THEY TRIED SWITCHING THE HAND PIECES AND THEY WERE STILL GETTING EXCESSIVE SPARKING. THEY DECIDED TO SWITCH GENERATORS AND STILL NO RESOLUTION. THEY ULTIMATELY DECIDED TO NOT USE THE GENERATOR. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760563 ↗
• MalfunctionMay 3, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING TWO GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE, THE HANDPIECES WAS EXCESSIVELY SPARKING. THEY TRIED SWITCHING THE HAND PIECES AND THEY WERE STILL GETTING EXCESSIVE SPARKING. THEY DECIDED TO SWITCH GENERATORS AND STILL NO RESOLUTION. THEY ULTIMATELY DECIDED TO NOT USE THE GENERATOR. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760531 ↗
• MalfunctionSep 18, 2020Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE UNIT WAS OUT OF POWER SPECIFICATION TESTING AT 150 OHMS, OVER 100 AT 200 WATTS. THERE WAS NO PATIENT INVOLVEMENT AND THE HCP WAS TRANSFERRED TO SERVICE AND REPAIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554049 ↗
• MalfunctionSep 17, 2020Fire; No Device Output; Failure to Prime; Fire; No Device Output; Failure to Prime

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE GENERATOR WAS BROKEN SITTING IN THE BIOMED DEPARTMENT WAITING FOR THE ADMINISTRATION TO MAKE A PURCHASING DECISION. IT WAS NOTED THAT THE HANDPIECE WAS USED WITH ANOTHER GENERATOR AND THE ISSUE WAS RESOLVED BY BRINING IN ANOTHER GENERATOR INTO THE ROOM. IT WAS NOTED THAT THE CAUSE OF THE ISSUE WAS NOT KNOWN BUT IN THE OPINION OF THE REP THOUGHT THE HANDPIECE MIGHT HAVE SPARKED FROM AN INCOMPLETE PRIME AND NOT FOLLOWING THE IFU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547199 ↗
• MalfunctionJul 24, 2020Fire; No Device Output; Device Damaged Prior to Use; Noise, Audible; Fire; No Device Output; Device Damaged Prior to Use; Noise, Audible

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A UNRESPONSIVE GENERATOR BEING SET UP FOR A PROCEDURE. IT WAS REPORTED THAT IT WAS NOTICED THAT THE SYSTEM WAS MAKING WEIRD NOISES AND ACTING FUNNY. THERE WAS FIRE/ARCHING/SMOKING FROM THE UNIT. THE FAN WAS CYCLING AND THE SCREEN WAS GOING DARK AND THEN LIGHTING UP RANDOMLY. IT WAS NOTED THAT THE GENERATOR WOULD FLASH AN ERROR CODE AND THEN IT WENT AWAY. THERE WAS NO PATIENT INVOLVEMENT AND THE CONTACT WAS TRANSFERRED TO SERVICE AND REPAIR. ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THERE WAS NO ERROR CODE AND NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320841 ↗