Enseal ETRIO325HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705036000280), received between Feb 6, 2018 and Oct 10, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, THE JAWS WERE NOT TO BE OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416637 ↗
• MalfunctionOct 2, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE JAWS WERE BROKEN. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852851 ↗
• MalfunctionApr 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING PANCREATICODUODENECTOMY, THE JAWS BECAME NOT TO OPEN DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822786 ↗
• MalfunctionJan 4, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UROLOGICAL PROCEDURE, THE JAWS DID NOT OPEN AT THE FUNCTIONAL TEST. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157839 ↗
• MalfunctionApr 12, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE JAWS BECAME NOT TO OPEN FULLY, AND THE KNIFE DID NOT REVERT TO THE ORIGINAL POSITION AFTER THE DEVICE CUT THE TARGET TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654093 ↗
• MalfunctionFeb 24, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN ESOPHAGECTOMY, THE JAWS BECAME MISALIGNED DURING USE. THE DEVICE DID NOT CLAMP THE HARD THINGS. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372799 ↗
• MalfunctionJan 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARIAN UNKNOWN PROCEDURE, THE USE THE JAWS FELL OUT OF THE DEVICE. DEVICE REPLACED. NO ADVERSE EVENT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216374 ↗
• MalfunctionApr 29, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, THE I-BLADE DID NOT GO BACK TO THE ORIGINAL POSITION AFTER THE SEALING. THE SURGEON RETURNED IT BY HAND. THE DEVICE WAS USED ON THE BLOOD VESSELS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009744 ↗
• MalfunctionAug 16, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS BECAME NOT TO OPEN FULLY DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8902896 ↗
• MalfunctionJul 16, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, THE JAWS BECAME NOT TO OPEN BEFORE USE FOR THE PATIENT. THERE IS NO POSSIBILITY THAT IT HAD FORGOTTEN TO UNLOCK THE SAFETY LOCK. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793677 ↗
• MalfunctionJun 21, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS HAD DIFFICULTY IN OPENING AND CLOSING DURING USE. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723473 ↗
• MalfunctionMar 2, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS BECAME NOT TO OPEN AFTER THE DEVICE COAGULATED THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7311110 ↗
• MalfunctionFeb 6, 2018Retraction Problem

  IT WAS REPORTED THAT DURING AN OPEN HEPATECTOMY, THE TRIGGER WAS NOT BACK TO THE ORIGINAL POSITION AND THE JAWS DID NOT OPEN AFTER CUTTING TISSUE. THE TRIGGER WAS OPENED BY HAND. THE SAME EVENT OCCURRED SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246287 ↗