Enseal NSLX125CRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10705036015444), received between Mar 23, 2021 and May 14, 2026 — classified as 2 deaths, 14 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (39 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE JAWS OF THE PRODUCT BECAME NOT TO OPEN IN A ROW. 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 25172132 ↗
• MalfunctionMay 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE JAWS OF THE PRODUCT BECAME NOT TO OPEN IN A ROW. 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 25171884 ↗
• MalfunctionMar 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLAMP WAS STUCK IN CLOSED POSITION. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651908 ↗
• MalfunctionMar 11, 2026Difficult to Open or Close; Firing Problem

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, IT FELT A STRANGE SENSATION THAT THE CUT BUTTON WAS DIFFICULT TO RETURN IN THE MIDDLE OF THE SURGERY. THEN, IT ACTIVATED SEVERAL TIMES. AFTER THAT, THE TISSUE WAS GRASPED AND ACTIVATED IT, BUT THE CUT BUTTON WOULD NOT RETURN AFTER CUTTING, AND THE JAWS WOULD NOT OPEN. BECAUSE THE AMOUNT OF TISSUE GRASPED WAS SMALL, THE MAIN BODY WAS PULLED OUT FROM THE BODY WITHOUT OPENING THE JAWS. THERE WERE NO PARTICULAR EFFECTS SUCH AS BLEEDING. 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 24570881 ↗
• MalfunctionFeb 2, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A TOTAL OPEN HYSTERECTOMY, THE DEVICE DID NOT OPEN AND CLOSE PROPERLY. THIS OCCURRED ABOUT 10 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON SAID THAT HE INTENDED TO CUT NORMAL TISSUE BUT CUT A FIBROID, WHICH WAS THICKER AND HARDER THAN NORMAL TISSUE. 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 24240688 ↗
• MalfunctionJan 23, 2026Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163038 ↗
• MalfunctionDec 19, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PANCREAS PROCEDURE THE JAWS BROKE APART. THE CUSTOMER CLAIMED THEY HAVEN'T STUFFED TO MUCH TISSUE IN THE JAWS OR LEVERAGED TO HEAVY. IT WAS REPLACED BY ANOTHER INSTRUMENT. THE PROCEDURE WAS DELAYED 5 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850577 ↗
• MalfunctionDec 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY, THE JAWS DID NOT OPEN 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23750903 ↗
• MalfunctionJul 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE JAWS COULD NOT BE OPENED BEFORE GRASPING THE TISSUE IN USE. THE HOSPITAL DID NOT REPLACE THE DEVICE AND USED AN ELECTRIC KNIFE, AND THE PROCEDURE WAS CONTINUED. WHEN THE NURSE MANIPULATES THE DEVICE SEVERAL TIMES, CONFIRMED AND MANIPULATED PHYSICALLY, THE JAWS OPENED. THEREFORE, THE CAUSE SEEMED TO BE BURNING. NO PIECES WERE FELL INTO THE PATIENT. ANOTHER COMPETITIVE 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 22479537 ↗
• DeathApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THIN VESSEL WAS SEALED WITH COVE AND AFTER 24H MASSIVE BLEEDING OCCURRED. WHEN OPENING THE PATIENT, IT WAS IDENTIFIED THAT THE SEALED VESSEL WAS OPEN. THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21882552 ↗
• DeathApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SEGMENTECTOMIA A THIN VESSEL WAS SEALED WITH COVE AND AFTER 24-HOURS MASSIVE BLEEDING OCCURRED. WHEN OPENING THE PATIENT, IT WAS IDENTIFIED THAT THE SEALED VESSEL WAS OPEN. THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21742520 ↗
• MalfunctionMar 26, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD BE USED EARLY IN PROCEDURE, BUT IN THE MIDDLE OF THE PROCEDURE, THE JAWS COULD NOT OPEN WITH HOLDING TISSUE. NO PIECES WERE FELL INTO THE PATIENT. 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 21698402 ↗
• MalfunctionJan 17, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT, DURING DISTAL GASTRECTOMY, THE KNIFE DID NOT PROCEED, AND THE HANDLE COULD NOT BE OPENED IN USE. IT WAS FOUND THAT THE TIP OF THE DEVICE WAS BENT. THE HANDLE COULD NOT BE OPENED HOLDING THE TISSUE, SO THE DOCTOR CHANGED THE PROCEDURE TO CUT AND SUTURE THE TISSUE. AFTER THAT, THE DEVICE COULD SEAL ONLY. NO PIECES WERE FELL INTO THE PATIENT. 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 21183590 ↗
• MalfunctionDec 11, 2024Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAP MOD RADICAL HYSTERECTOMY RIGHT SALPINGO OOPHORECTOMY, OMENTECTOMY, DEBULKING PROCEDURE, WHEN SEALING OVER THE OVARIAN ARTERY, THE KNIFE BLADE WOULD NOT DEPRESS. SURGEON TRIED TO OPEN THE HANDLE AND TRIED TO DEPRESS THE CUT BUTTON, DEVICE JAWS WOULD NOT OPEN. SURGEON PULLED TO REMOVE THE DEVICE OFF THE UTERINE ARTERY WHICH CAUSED BLEEDING. SURGEON WAS ABLE TO REPAIR AND STOP BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20905988 ↗
• MalfunctionNov 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DOG HYSTERECTOMY THE PAD DETACHMENT AT FIRST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665897 ↗
• MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING OPEN GASTRECTOMY, IN THE MIDDLE OF THE SURGERY, IT WAS NOTICED THAT THE TIP OF THE SHAFT WAS BROKEN. THE DOCTOR SAID THAT HE DID NOT PUT EFFORT FORCIBLY. THERE WERE NO PIECES LEFT IN THE PATIENT. THERE IS A POSSIBILITY OF THE REASON OF THIS CASE THAT A NURSE DID NOT CHECK PRECAUTIONS PROPERLY. 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 19739447 ↗
• InjuryMay 6, 2024Failure to Read Input Signal; Adverse Event Without Identified Device or Use Problem; Failure to Read Input Signal; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE COAGULATION BUTTON OF THE ADVANCED BIPOLAR SCISSORS DEVICE DID NOT WORK. THE PROCEDURE WAS DELAYED 10 MINUTES. ANOTHER DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 19248725 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING OPEN PEDIATRIC HERNIA REPAIR, THE JAWS WERE BROKEN WHEN THE DEVICE CUT HARD TISSUE. THE DEVICE WAS USED AS USUAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197551 ↗
• InjuryApr 19, 2024Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC PNEUMONECTOMY, THERE WAS BLEEDING FROM HILUM, AND THE AMOUNT OF BLEEDING WAS UNKNOWN. THE DEVICE WAS USED ON BLOOD VESSELS. THE PROCEDURE WAS CONVERTED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE TO COMPLETE THE CASE. ALSO, ADDITIONAL SUTURING WAS PERFORMED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19146930 ↗
• MalfunctionMar 25, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING ITS USE, THE DEVICE'S JAWS REMAINED STUCK TO THE TISSUE (RISK OF TEARING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968956 ↗
• MalfunctionJan 16, 2024Difficult to Open or Close; Difficult to Open or Close

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517605 ↗
• MalfunctionNov 16, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, JAWS BECAME NOT TO BE OPEN EVEN WITHOUT RATCHET ON AFTER TEN MINUTES OF 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 18149070 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE KNIFE BREAKS OFF DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075269 ↗
• MalfunctionOct 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, WHEN THE DOCTOR BEGAN THE UNKNOWN SURGICAL PROCEDURE, THE PRODUCT WAS OPENED AND CONNECTED TO THE GENERATOR WITHOUT ANY MAJOR PROBLEMS. A FEW MINUTES AFTER STARTING THE PROCEDURE, THE DOCTOR CLOSED THE MATERIAL'S JAW AND IT NO LONGER OPENED. THE PROCEDURE CONTINUED WITHOUT FURTHER OCCURRENCES AND WAS COMPLETED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998903 ↗
• MalfunctionOct 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, WHEN THE DOCTOR BEGAN THE UNKNOWN SURGICAL PROCEDURE, THE PRODUCT WAS OPENED AND CONNECTED TO THE GENERATOR WITHOUT ANY MAJOR PROBLEMS. A FEW MINUTES AFTER STARTING THE PROCEDURE, THE DOCTOR CLOSED THE MATERIAL'S JAW AND IT NO LONGER OPENED. THE PROCEDURE CONTINUED WITHOUT FURTHER OCCURRENCES AND WAS COMPLETED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998840 ↗