Aquamantys™ 23-317-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000280956), received between May 17, 2021 and Aug 14, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250500 ↗
• MalfunctionJul 28, 2025Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE COULDN'T STOP BLEEDING DURING A PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22629634 ↗
• InjuryJun 13, 2025No Device Output; No Device Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A CASE, WHEN SITE OPENED THE PACKAGE AND USED THE HANDPIECE, IT EXPERIENCED NO OUTPUT. INITIALLY, IT WAS SUSPECTED THAT THE HOST WAS FAULTY, SO USED WITH ANOTHER HOST, BUT STILL DEVICE HAD NO OUTPUT. SITE TRIED HANDPIECE WITH TWO DIFFERENT MACHINES BUT ISSUE STILL PERSISTED. SO IT WAS REPLACED WITH A NEW HANDPIECE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A SERIOUS HARM ASSOCIATED WITH PATIENT. FAILED TO USE THE DEVICE WHICH LEAD TO INCREASE BLEEDING DURING SURGERY AND REQUIRED BLOOD TRANSFUSION. THE SURGICAL PROCEDURE PERFORMED DURING THE EVENT OCCURRED WAS RIGHT HEMI LIVER RESECTION AND THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22202794 ↗
• MalfunctionMar 10, 2022No Device Output; Failure to Shut Off; No Device Output; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A LIVER PROCEDURE, THE HANDPIECE WAS STUCK ON ACTIVATION. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721306 ↗
• MalfunctionFeb 22, 2022Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT AFTER COMPLETION OF PROCEDURE, THE TIPS OF THE DEVICE HAD SALINE FLOW CONTINUE, AS WELL AS BIPOLAR ACTIVATION WITHOUT ANYONE DEPRESSING ACTIVATION BUTTON. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578261 ↗
• MalfunctionMay 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT UPON PASSING THE HANDPIECE DEVICE TO THE SURGICAL FIELD AND BEING CONNECTED TO THE EQUIPMENT, THE DOCTOR PERFORMED THE FUNCTIONAL TEST WITH THE BUTTON AND FOUND THAT THE METAL STEM WAS ROTATING ON ITS AXIS, THEN THEY TESTED IT TO COAGULATE AND REALIZE THAT IT WAS NOT THERE. WORKING AND BECAUSE THERE WAS NO PASSAGE OF ENERGY, THE DOCTOR DECIDED NOT TO USE IT AND REMOVE IT FROM THE SURGICAL FIELD. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS NOTED THAT THE TIP DID NOT BREAK OFF FROM THE HANDPIECE. THE FUNCTIONAL TEST WITH THE BUTTON AND FOUND THAT THE METAL STEM WAS ROTATING ON ITS AXIS, THEN THEY TESTED IT TO COAGULATE AND REALIZE THAT IT WAS NOT THERE. BOTH CUT AND COAG NEVER WORKED BECAUSE THE METAL PART WAS NOT MAKING CONTACT WITH THE HANDPIECE. THE GENERATOR WAS WORKING WELL. THERE WAS NO PATIENT INVOLVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832286 ↗