Enseal ETRIO345HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036000303), received between Sep 6, 2019 and Dec 1, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS OF THE DEVICE WOULD NOT OPEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909186 ↗
• MalfunctionOct 7, 2020Appropriate Device Problem Term/Code Not Available; Activation Problem; Appropriate Device Problem Term/Code Not Available; Activation Problem

  IT WAS REPORTED THAT DURING A ROBOTIC PROSTATECTOMY, AN ENSEAL DEVICE DID NOT WORK PROPERLY. POTENTIAL THAT A PIECE OF THE JAWS BROKE OFF DURING USE. THE PIECE WAS NOT LOCATED INTRA-OPERATIVELY. THE SURGEON WILL EXPLORE AGAIN WHEN THE PATIENT RETURNS TO THE OFFICE, AND THEN THE PATIENT WILL BE FURTHER EXAMINED. SURGERY WAS DELAYED AN UNKNOWN AMOUNT OF TIME DUE TO THIS REPORTED EVENT. THE SECOND DEVICE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10641382 ↗
• MalfunctionAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIATAL HERNIORRAPHY, THE DISTAL TIP OF THE ENSEAL FELT TO HAVE BROKEN OFF. SURGERY WAS NOT DELAYED DUE TO THE TIME REPORTED EVENT. THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459074 ↗
• MalfunctionSep 6, 2019Mechanical Problem

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE THE SURGEON DID NOT GET THE FINAL NOTIFICATION THAT HE HAD BURNED AND TRANSECTED THE TISSUE. HE OPENED A SECOND DEVICE AND HAD THE SAME ISSUE. HE COMPLETED THE PROCEDURE WITH THE SECOND DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972479 ↗