Aquamantys™ 23-113-1 (UDI 00763000280895)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000280895), received between May 3, 2021 and Oct 17, 2025 — classified as 1 injury, 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDPIECE TUBING WAS FOUND TO HAVE A MATERIAL PUNCTURE OR HOLE, RESULTING IN THE DEVICE DRIPPING ONTO THE FLOOR. THE IRRIGATION FROM THE BAG HAD BEEN USED TO IRRIGATE AN INTEGRA PATCH FOR IMPLANTATION. THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322358 ↗
• MalfunctionSep 4, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE BUTTON WAS NOT WORKING. A NEW HANDPIECE WAS BROUGHT IN, AND IT FUNCTIONED AS DESIGNED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INCIDENT HAPPENED AT THE START OF THE CASE. PATIENT WAS PRESENT AND THE CASE WAS DELAYED SLIGHTLY TO REPLACE WITH NEW HANDPIECE AND IT WAS REPORTED THAT THE PROCEDURE PERFORMED AT THE TIME OF EVENT OCCURRED WAS A SPINE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963556 ↗
• MalfunctionFeb 20, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT SALINE LEAKED NONSTOP AT HIGH LEVELS DESPITE SELECTING DIFFERENT FLOW SETTINGS. THIS HAPPENED WITH 2 HANDPIECES. THE HANDPIECES WERE REMOVED FROM THE ROOM BY THE STAFF. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418585 ↗
• MalfunctionFeb 3, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT SALINE LEAKED NONSTOP AT HIGH LEVELS DESPITE SELECTING DIFFERENT FLOW SETTINGS. THIS HAPPENED WITH 2 HANDPIECES. THE HANDPIECES WERE REMOVED FROM THE ROOM BY THE STAFF. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298145 ↗
• MalfunctionOct 18, 2024Fire; Fire

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED DURING THE EVENT WAS SPINE CASE AND THERE WAS A MINIMAL DELAY IN SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479533 ↗
• 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 17260667 ↗
• MalfunctionMar 31, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT WHEN USING THE HANDPIECE IT SPARKED. THIS SPARK CAUSED THE SITE TO OPEN ANOTHER HANDPIECE TO CONTINUE THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656187 ↗
• MalfunctionAug 4, 2022Break; Excess Flow or Over-Infusion; Break; Excess Flow or Over-Infusion

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT BEFORE THE SURGICAL OPERATION, AFTER OPENING, IT WAS CONNECTED TO THE GENERATOR FOR PREPARATION. WHEN PRIMING IT, THE SALINE LEAKED AND BREAKAGE WERE DETECTED. BECAUSE IT WAS UNUSED, THE TAPE WAS APPLIED AND FIRST AID WAS PERFORMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15167268 ↗
• 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 11760561 ↗
• 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 11760543 ↗