Enseal ETRIO314HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036000273), received between May 7, 2019 and Oct 19, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GENECOLOGY PROCEDURE AND THE BUTTON TO ADVANCE THE KNIFE BLADE WOULD NOT WORK. THERE WAS NO ADVERSE DAMAGE TO THE PATIENT. THEY OPENED ANOTHER TYPE OF DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633319 ↗
• MalfunctionApr 21, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE DEVICE WAS UNRESPONSIVE AFTER A FEW ACTIVATIONS. THEY TRIED UNPLUG AND REPLUG IT AND RESTART GEN11 BUT IT DIDN'T WORK. SO THEY OPENED ANOTHER NEW ETRIO314H TO CONTINUE THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701616 ↗
• MalfunctionMay 7, 2019Display or Visual Feedback Problem; Difficult to Open or Close; Therapeutic or Diagnostic Output Failure

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588201 ↗