ENSEAL X1 NSLX120LRecalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 10705036015024), received between Nov 21, 2017 and Sep 23, 2026 — classified as 2 deaths, 45 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (58 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 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Open or Close

  It was reported that during an unknown procedure, the handles were pressed to close and they got stuck without the possibility of being able to open. No patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868800 ↗
• MalfunctionSep 11, 2026Structural Problem

  It was reported that during a Laparotomy procedure the device was opened and the handle broke off. Opened a new device to continue operation. No patient consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733473 ↗
• MalfunctionMay 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE DEVICE CLAMPED DOWN AND WOULD NOT RELEASE, RESULTING IN THE JAW NOT OPENING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233331 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED DEVICE ¿MIS FIRED¿ AND A PIECE CAME OFF THE JAWS DURING AN OPEN TOTAL ABDOMINAL HYSTERECTOMY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735165 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE'S HANDLE LATCH BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291697 ↗
• MalfunctionJan 26, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A VET PROCEDURE, ON FIRST USE, THE TRIGGER DROPPED OUT AND CAME LOOSE, PREVENTING IT FROM CLOSING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177189 ↗
• MalfunctionDec 15, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY THE HANDLE WHEN THEY OPEN AND CLOSE IT GET KEEP STOCK AND WOULDN'T OPEN. SO, IF CLOSE THE JAW OFF THE DEVICE, SEAL AND CUT THEN IT WOULDN'T OPEN BACK. THEY SAID IT BASICALLY DOING THAT AS SOON IT CAME OUT OF THE BOX. THEY OPEN A NEW DEVICE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804820 ↗
• MalfunctionDec 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE HANDLE DID NOT OPEN WHEN THE DEVICE WAS USED. THERE WAS NO EFFECT ON 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 23744796 ↗
• MalfunctionDec 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE HANDLE DID NOT OPEN WHEN THE DEVICE WAS USED. ANOTHER DEVICE WAS USED. THERE WAS NO EFFECT ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744708 ↗
• MalfunctionNov 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THE SURGEON WAS ACTIVATING IT THE HANDLE WOULDN'T UNLOCK. NO ADVERSE IMPACT PATIENT/USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631563 ↗
• MalfunctionNov 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THE SURGEON WAS ACTIVATING IT THE HANDLE WOULDN'T UNLOCK. ONE OF THEM IS IN A COMPLETE LOCK BUT HE WAS ABLE TO PULL IT OFF THE PATIENT. NO ADVERSE IMPACT PATIENT/USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631496 ↗
• MalfunctionNov 20, 2025Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLAMP WAS USED AND REMAINED ATTACHED TO THE TISSUE, UNABLE TO OPEN IT. WE HAD TO TEAR THE FABRIC TO RELEASE IT. THE CLAMP WAS NOT UNLOCKED. THERE ARE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607376 ↗
• MalfunctionNov 20, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A TOTAL CYSTECTOMY, THE JAWS DID NOT OPEN EVEN WHEN THE RATCHET WAS RELEASED AFTER SEALING AND CUTTING THE TISSUE. THERE WAS NO TISSUE DAMAGE WHEN THE JAWS WERE FORCIBLY OPENED AND CLOSED. 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 23604944 ↗
• MalfunctionNov 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, THE PACKAGE WAS FOUND DAMAGED. 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 23509856 ↗
• MalfunctionAug 6, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TRIGGER THAT TRIGGERS COAGULATION STUCK AND DID NOT RETURN TO THE INITIAL POSITION, MAKING IT IMPOSSIBLE TO USE THE DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728787 ↗
• MalfunctionJun 9, 2025Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE LOCKED UP. THE JAW WOULD NOT OPEN, AND IT WAS TEARING THE TISSUE ON THE REMOVAL. THEY WHERE ABLE TO OPEN AND REPLACE IT WITH A NEW ONE. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168149 ↗
• MalfunctionApr 21, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING BOWEL RESECTION PROCEDURE THE CUT BUTTON WAS NOT WORKING. NO PATIENT HARM REPORTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875511 ↗
• MalfunctionFeb 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING AN UNKNOWN PROCEDURE THE DEVICE: THE JAW REMAINS CLOSED AFTER THE CAUTERY CYCLE. THE SURGEON COULD NOT OPEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296603 ↗
• MalfunctionJan 31, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THE DEVICE LOCKED WITHIN THE PROCEDURE AND COULD NOT BE OPENED. ANOTHER DEVICE WAS OPENED AND USED TO CONTINUE THE PROCEDURE. THE SURGERY WAS DELAYED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283290 ↗
• MalfunctionDec 9, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE DEVICE WAS ACTIVATING BY ITSELF. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878262 ↗
• MalfunctionNov 19, 2024

  SURGEON WAS USING THE DEVICE. THE DEVICE WAS NOT CLOSING AND GIVING ERROR MESSAGE. DEVICE WAS REMOVED AND REPLACED WITH NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722860 ↗
• MalfunctionNov 13, 2024Difficult to Open or Close; No Apparent Adverse Event; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY MASS DISSECTION AND TOTAL ABDOMINAL HYSTERECTOMY THAT WHILE DISSECTING THE IP LIGAMENT DEVICE WAS CLOSED TO SEAL AND CUT BUT THE JAWS WOULD NOT OPEN. TROUBLE SHOOTING STEPS WERE TAKEN BUT THE JAWS WOULD NOT OPEN. DEVICE WAS REMOVED BY DISSECTED AROUND IT IS USING A COMPETITOR'S DEVICE. COMPETITORS DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675440 ↗
• MalfunctionOct 18, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THEY WERE UNABLE TO OPEN JAWS OF INSTRUMENT AND REQUESTED TROUBLESHOOTING IN OPENING JAW OF PRODUCT. WENT OVER STEPS OF USE WITHOUT JAW OPENING. INSTRUMENT WAS REMOVED OFF OF PATIENT PRIOR TO CALL AND ANOTHER INSTRUMENT WAS USED TO FINISH CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482184 ↗
• MalfunctionSep 30, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THERE WAS TISSUE ADHESION ON THE JAWS. NO PATIENT CONSEQUENCES. THIS IS A VET PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332804 ↗
• MalfunctionAug 14, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE DEVICE "WOULD NOT RELEASE". THERE WAS NO PATIENT CONSEQUENCES REPORTED. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985435 ↗