Enseal NSEAL525RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705036000037), received between Apr 17, 2019 and Sep 27, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT PART OF THE JAW CAME OFF. ONE SIDE OF THE JAW DETACHED FROM THE DEVICE. FRAGMENT WAS RECOVERED AND RETURNING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20317479 ↗
• MalfunctionApr 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE THE ENSEAL DID NOT WORK. UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16703105 ↗
• MalfunctionNov 23, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE ANAL EXAM UNDER ANESTHESIA THE ENSEAL DEVICE JAWS STOPPED OPENING AND CLOSING. CASE COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861066 ↗
• MalfunctionOct 12, 2021Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY THE TIP BROKE OFF AND THE JAWS NO LONGER CLOSED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615098 ↗
• MalfunctionJun 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN XLAP SIGMOID RESECTION THE TOP JAW WAS BENT UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957441 ↗
• MalfunctionApr 30, 2021Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE THAT THE TIP WAS BROKEN BUT DID NOT DETACH. THE JAW WOULD NO LONGER CLOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753712 ↗
• MalfunctionFeb 22, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A VAGINAL HYSTERECTOMY THE JAW OF THE DEVICE WAS BENT AND INOPERABLE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357823 ↗
• MalfunctionJul 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LIVER RESECTION, THE TIP CAME OFF OF TWO SUBSEQUENT DEVICES AND FELL INTO THE STERILE FIELD. ALL FRAGMENTS WERE RETRIEVED WITH EASE. A THIRD DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325552 ↗
• MalfunctionJul 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LIVER RESECTION, THE TIP CAME OFF OF TWO SUBSEQUENT DEVICES AND FELL INTO THE STERILE FIELD. ALL FRAGMENTS WERE RETRIEVED WITH EASE. A THIRD DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289045 ↗
• MalfunctionApr 17, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE UPPER JAW OF THE ENSEAL INSTRUMENT BROKE OFF INTO THE PATIENT AND IT WAS NOT FOUND. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8523186 ↗