Enseal NSLX137CRecalls & reported problems

Summary

The FDA's MAUDE database contains 344 adverse event reports that list this exact device (DI 10705036015468), received between Mar 28, 2019 and Sep 28, 2026 — classified as 3 deaths, 69 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (162 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 344 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Failure to Read Input Signal; Adverse Event Without Identified Device or Use Problem

  It was reported that, during Vaginal Natural Orifice Transluminal Endoscopic Surgery, the doctor grasped the right uterosacral ligament with forceps and coagulate the area immediately near adjacent to the right uterosacral ligament using ENSEAL. An error message like ¿metal error¿ was displayed, so the device was moved a few millimeters away from the forceps and was reactivated. It felt like it took longer than usual for the completion sound to play. After that, ENSEAL completed the operation without any problems. The inner surface of the right labium minus presented a condition resembling a burn. The same device was used as is to complete the case. No further information is available.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50916182 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808505 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808466 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event

  It was reported that during an unknown procedure initially the device was performing fine. Then after seal and press cut on the device, it stuck. Jaw failed to open on the device. Able to open the jaw of the device by force when outside of patient body, by inserting pull force on the closing handle. A bipolar and normal scissors were used to remove the device from the uterus. Another device was used to complete the surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808371 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  It was reported that during hysterectomy procedure the distal jaw broke at the hinge. Opened a new one and proceeded with the procedure. No negative patient outcomes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672846 ↗
• MalfunctionSep 3, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50588396 ↗
• MalfunctionAug 21, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375365 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164951 ↗
• MalfunctionJun 29, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE KNIFE ONLY RETURNED UNTIL ABOUT HALFWAY DURING 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 25652675 ↗
• MalfunctionJun 12, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO THE UNKNOWN PROCEDURE, IT WAS NOTED THAT THE PRODUCT LISTED ON THE BOX WAS DIFFERENT FROM WHAT WAS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491219 ↗
• MalfunctionJun 12, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE, THE DEVICE RACK LOCKED AND NO LONGER OPENED, REQUIRING THE OPENING OF A NEW FORCEPS. THE PRODUCT HAS BEEN DISCARDED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491033 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW METAL BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445187 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE UNKNOWN PROCEDURE, THE PATIENT DEVELOPED HEMATOMAS POSTOPERATIVELY, APPROXIMATELY ONE WEEK LATER.

  Patient problems: Hematoma

  MAUDE report 25319308 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE UNKNOWN PROCEDURE, THE PATIENT DEVELOPED HEMATOMAS POSTOPERATIVELY, APPROXIMATELY ONE WEEK LATER.

  Patient problems: Hematoma

  MAUDE report 25318930 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED HEMATOMA POSTOPERATIVELY, APPROXIMATELY ONE WEEK LATER.

  Patient problems: Hematoma

  MAUDE report 25318545 ↗
• MalfunctionMay 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP SIGMA THE INSTRUMENT COULD NOT BE OPENED ANYMORE AND WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233160 ↗
• MalfunctionMay 4, 2026Failure to Read Input Signal; Activation, Positioning or Separation Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING AN UNKNOWN OB-GYN SURGERY, THE JAWS OF THE ENSEAL BECAME NOT TO BE OPENED DURING THE FINAL HEMOSTASIS. CLICKING THE RATCHET DIDN'T OPEN, AND THE BUTTON ALSO DIDN'T FUNCTION. IT'S UNCLEAR IF IT'S RELATED TO THE JAW OPENING/CLOSING MALFUNCTION, BUT BEFORE THE MALFUNCTION OCCURRED, AN UNKNOWN ERROR MESSAGE WAS DISPLAYED ON THE GEN 11. 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 25073516 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875221 ↗
• MalfunctionApr 8, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPY THE JAW IS STUCK AND IT COULD NOT OPEN OR CLOSE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821061 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC NEPHROURETERECTOMY, THE JAWS BECAME NOT OPEN AND THE BOUNDARY WITH THE SHAFT IS DAMAGED. (REPORT OF MALFUNCTION FROM OPERATING ROOM STAFF.) THE SURGEON HAS MOVED ON TO THE NEXT SURGERY, SO THE DETAILED SITUATION IS UNKNOWN. THE JAWS OF THE PRODUCT ARE NOT OPENING, AND SOMETHING LIKE A TISSUE IS STUCK IN IT. 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 24733979 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A HYSTERECTOMY DURING THE USE OF THE DEVICE, THE BLADE IS LOCKED AND EXPOSED. THE DEVICE CAN NO LONGER BE USED. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716108 ↗
• MalfunctionMar 26, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY THE FORCEPS MALFUNCTIONED WITH LOCKING OF THE JAW AND UTERINE BLADE. REPLACED THE MATERIAL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704575 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE MYOMECTOMY PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605353 ↗
• MalfunctionMar 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN OB-GYN SURGERY, WHEN THE ABDOMINAL WALL WAS GRASPED AND ACTIVATED, THE JAWS COULD NOT BE OPENED. AFTER MANUALLY MOVING THE GRIP SEVERAL TIMES, THE JAWS OPENED SLIGHTLY, SO IT WAS PEELED OFF FROM THE ABDOMINAL WALL AND REMOVED FROM THE BODY. AFTER THAT, THE JAWS COULD NOT BE MOVED AGAIN. 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 24536558 ↗
• MalfunctionFeb 12, 2026Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A VNOTES PROCEDURE THE SURGEON INDICATED THE ENSEAL X1 ¿GOT REALLY HOT, JAW LOCKED AND DID NOT COMPLETE CYCLE, AS A RESULT TORE TISSUE INSTEAD OF SEALING IT.¿ REPORTED DELAYED PROCEDURE BY 30 MINS AND PATIENT HAD A 3000CC BLOOD LOSS AND SHOULD HAVE BEEN 50CC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24324666 ↗