Enseal NSLG2C14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036014164), received between Sep 20, 2018 and May 12, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS HARD TO SQUEEZE WHEN CLOSING THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812722 ↗
• MalfunctionMar 23, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW OF THE ENSEAL COULD NOT OPEN NEAR THE END OF THE SURGERY. THEY CLEANED THE JAW AND THE JAW STILL COULD NOT OPEN. IT WAS CHOSEN TO NOT CONTINUE THE SURGERY WITH ENSEAL. INSTEAD, SHE USED HAND SEWED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557887 ↗
• MalfunctionNov 11, 2020Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT THE JAW OF THE DEVICE CANNOT BE OPENED AND CLOSED PROPERLY DURING THE SURGERY. IT WAS OBSERVED THE I-BLADE OF THE UPPER JAW AND THE HINGE JOINT WERE DAMAGED, THEREFORE THE JAW CANNOT BE CONTROLLED BY THE HANDLE NORMALLY. THE SURGERY WAS COMPLETED BY OPENING A NEW PACK OF THE SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824457 ↗
• MalfunctionSep 2, 2020Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BOWEL PROCEDURE, FIFTEEN OR TWENTY MINUTES INTO THE CASE THE THERE WAS AN ERROR AND THE DEVICE STUCK CLOSED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481843 ↗
• MalfunctionOct 25, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DOCTOR HAD JUST STARTED AN OPEN TAH. THE STAFF CONNECTED THE DEVICE TO THE GENERATOR AS USUAL. ONCE THE CASE OFFICIALLY STARTED AND THE SURGEON WAS ABOUT TO USE THE ENSEAL AND THE DEVICE WOULD NOT CLAMP PROPERLY ON TISSUE AND THE ENERGY WAS WORKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8007356 ↗
• MalfunctionOct 17, 2018Break

  IT WAS REPORTED THAT AT THE BEGINNING OF AN ABDOMINAL TOTAL HYSTERECTOMY, WHEN USING FOR THE FIRST TIME, WHEN CLOSING ON TISSUE IT BROKE AT THE HEIGHT OF THE JAW, RESULTING IN THE LOSS OF THE LOOSE PIECE. THE NECESSARY MEASURES WERE TAKEN TO VERIFY THAT SAID PART OF THE INSTRUMENT WAS NOT LODGED IN THE PATIENT'S CAVITY. AFTER RADIOLOGICAL STUDY IT IS CONFIRMED THAT THE PIECE DID NOT AFFECT THE PATIENT OR THE USER IN ANY WAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975673 ↗
• MalfunctionSep 20, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895989 ↗