DUALTO Energy System ETHEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705036038389), received between May 15, 2026 and Aug 14, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  It was reported that, during a total laparoscopic hysterectomy with bilateral salpingectomy for uterine fibroids, bleeding from the port site was cauterized using a right-angle electrode of the Probe Plus during wound closure. An electric current ran through the muscle retractor that was placed in the surgical field at that time, causing a second-degree burn. The attending physician's opinion is that it may have been an electrical discharge. The patient is female, but it is currently confirming the treatment she received for this incident, her condition after treatment, and the patient background information. No further information is available.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50255546 ↗
• InjuryAug 5, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50143791 ↗
• InjuryAug 5, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50143754 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Hematoma

  MAUDE report 50142747 ↗
• MalfunctionMay 15, 2026Self-Activation or Keying; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING A LAP SLEEVE GASTRECTOMY, THEY HAD COMPLETED USE OF ENSEAL X1, HE WAS CHANGING INSTRUMENTS AND RANDOMLY AN "ENERGY MODULE ERROR" SCREEN POPPED UP. THE SCREEN WAS FROZEN FOR ABOUT 10 SECONDS AND THEN IT CLEARED. AFTER THE ERROR DISAPPEARED, THE ENSEAL STARTED ACTIVATING WITH NO ONE TOUCHING THE SEAL BUTTON WHILE SITTING ON THE MAYO STAND AND WENT ON ACTIVATING UNTIL THEY PULLED THE PLUG ON THE GENERATOR AFTER ABOUT 10 SECONDS. THEY RESTARTED THE GENERATOR AND EVERYTHING WORKED FINE; THE CASE WAS FINISHED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183445 ↗