Enseal NSLG2S14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036014171), received between Dec 13, 2017 and Jun 24, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionJun 24, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE DEVICE STOPPED WORKING. WORKED FOR A FEW MINUTES. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602575 ↗
• MalfunctionFeb 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW IS NOT OPENING AND GOT STUCK IN THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768257 ↗
• MalfunctionFeb 21, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748627 ↗
• MalfunctionJul 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE BLADE BROKE OFF BUT NEVER DETACHED. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092945 ↗
• MalfunctionMar 24, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE NSLG2S14 ENSEAL TISSUE SEALER G2 JAW WAS UNABLE TO OPEN. HCP HAS TO FORCED OPEN THE JAW. HCP COMPLAINED THAT THERE WAS CRUSH SOUND DURING CLOSING THE JAW. AFTER RETRIEVE THE SHEARS, SHE FOUND THERE WAS A CRACKED AT THE CLOSING HANDLE. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875573 ↗
• MalfunctionJul 9, 2019Break; Detachment of Device or Device Component; Output Problem

  IT WAS REPORTED THAT WHEN CONNECTING THE ENSEAL TO THE GEN11, THE GENERATOR RECOGNIZED IT AS USUAL, BUT LATER IT BEGAN TO INDICATE THAT THERE WAS AN ERROR IN THE BLADES, AND THAT THEY HAD TO BE SEPARATED. THEN THE GEN11 ASKED TO DISCONNECT THE PRODUCT. THE PRODUCT WAS DISCONNECTED AND RECONNECTED. WHEN TRYING TO USE THE ENSEAL, THE JAW BROKE WHEN USING IT ON THE ABDOMINAL WALL. THE MOVABLE CLAW OF THE CLAMP WAS THE ONE THAT BROKE AND FELL IN THE PATIENT, THIS PIECE WAS REMOVED BY THE DOCTOR, THE PATIENT WAS NOT HURT AT ANY TIME. THERE WAS NO DAMAGE TO THE PATIENT, THE SURGERY WAS PERFORMED WITH SILKS, AS THERE WERE NO MORE DEVICES AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771996 ↗
• MalfunctionDec 13, 2017Break

  IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7115515 ↗