Enseal NSLG2C35Recalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 10705036014140), received between Dec 11, 2017 and Jul 31, 2026 — classified as 6 injuries, 205 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (69 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 211 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Difficult or Delayed Activation

  It was reported that during a Total Laparoscopic Hysterectomy, the tip of the device would not to activate. The procedure was completed using a replacement device. The tissue was not grasped, so there was no impact 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 50098557 ↗
• MalfunctionFeb 27, 2026Device Alarm System

  IT WAS REPORTED THAT DURING A GASTRIC RESECTION THERE WAS AN ERROR DUE FAULT BUTTON. THE PROCEDURE WAS DELAYED 10 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470072 ↗
• MalfunctionJul 18, 2025Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN THE DOCTOR WAS OPERATING ON VAGINAL CANAL INCISION AT THE LATTER HALF OF THE PROCEDURE, THE DOCTOR FELT THAT THE KEENNESS OF G2 IS BAD. AT THAT TIME, THE WOUND CLOSURE WAS DONE WITHOUT CONFIRMING THE DEVICE, BUT IT WAS FOUND OUT AFTER THE PROCEDURE THAT THE ONE SIDE OF THE FASTENER PART OF I BLADE WAS DEFECTED. THE X-RAY WAS DONE JUST IN CASE, BUT IT SEEMED THERE WERE NO ANOTHER PART IN THE PATIENT¿S BODY. HOW TO DEAL WITH THIS IS GOING TO BE CONSULTED AT THE HOSPITAL. NO PIECES WERE LEFT INSIDE 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 22541616 ↗
• MalfunctionMar 7, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS DO NOT CLOSE MECHANICALLY. A DIFFERENT DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547610 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHITE TISSUE PAD WAS COMPLETELY DETACHED. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. 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 20003607 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, THE I-BLADE WAS BROKEN WHEN THE DEVICE PINCHED HARD TISSUE. IT WAS USED ON UTERUS. IT WAS UNKNOWN WHETHER THERE WAS BLEEDING. IT WAS EXPLAINED ON THE PHONE THAT THE BROKEN PIECES WERE METAL, AND IT IS GOING TO BE CHECKED BY X-RAY JUST IN CASE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949597 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A OOPHORECTOMY, THE DEVICE BROKE. BROKE INSIDE OF THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT. CASE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467878 ↗
• InjuryMay 22, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN THE DEVICE WAS USED TO CUT THE VAGINAL WALL IN THE DIRECTION OF 9 O'CLOCK, THE DEVICE COULD NOT ACTIVATE. THE DOCTOR CHECKED, AND IT WAS FOUND THAT THE ELECTRODE AND PTC WERE PEELED OFF AND STUCK TO VAGINAL WALL. UNKNOWN PIECES WERE FOUND IN EXCAVATIO VESICOUTERINA AND REMOVED. THE DEVICE WAS REMOVED BENDING PTC FROM THE INCISION. IN THAT TIME, THE COMING OUT ELECTRODE WAS PULLED AND COME OFF FROM THE DEVICE. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT USING THE ENSEAL. THE INCISIONS WERE CLOSED, AND THE PATIENT WAS AWOKEN FROM ANESTHESIA. AFTER THE PROCEDURE, X-RAYS WERE TAKEN AND SHOWED THAT 3 PIECES WERE LEFT IN THE PATIENT. THE PATIENT WAS UNDER ANESTHESIA AGAIN, AND PIECES WERE REMOVED BY LAPAROSCOPIC PROCEDURE. ALL PIECES SHOWN BY X-RAYS WERE REMOVED, AND X-RAYS WERE TAKEN AGAIN, BUT NO PIECES WERE SHOWN. THE DOCTOR WAS CONCERNED ABOUT THE EFFECTS OF THE PIECES IF THEY REMAINED IN THE BODY. THE DOCTOR ALSO THOUGHT THAT IT WAS POSSIBLE THAT THE DEVICE HAD BEEN ALREADY BROKEN BEFORE USING ON VAGINAL WALL BECAUSE THE PIECES SCATTERED IN AREAS FAR FROM THE VAGINAL WALL. THE PROCEDURE STARTED AT 9 O'CLOCK, AND REMOVA

  Patient problems: Foreign Body In Patient

  MAUDE report 19369784 ↗
• MalfunctionMay 15, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VAGINAL HYSTERECTOMY THE DEVICE GOT STUCK, UNABLE TO OPEN OR CLOSE THE JAW, LEAVING IT DISABLED. CHANGE OF DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321850 ↗
• MalfunctionMay 7, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE DEVICE COULD NOT OPEN. 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 19259488 ↗
• MalfunctionApr 2, 2024Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN THE DEVICE APPROACHED TO THE THICK AND HARD TISSUE, THE HANDLE DID NOT PROCEED, AND THE JAWS COULD NOT CLOSE COMPLETELY, AND THE DEVICE COULD NOT BE PULLED OUT FROM A TROCAR. THE I-BLADE HAD COME OFF FROM THE RAIL OF THE JAW. THE DOCTOR PINCHED THE I-BLADE WITH FORCEPS AND THE JAW WAS CLOSED, AND THE DEVICE COULD BE PULLED OUT FROM A TROCAR. THE DEVICE WAS USED ON LIGAMENTS. 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 19022470 ↗
• MalfunctionMar 18, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE'S JAW LOCKED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920489 ↗
• MalfunctionFeb 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP SIGMA THE INSTRUMENT HAS NO LONGER RELEASED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758552 ↗
• MalfunctionFeb 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A FUNDOPLICATIO THE INSTRUMENT NO LONGER OPENED AND COULD NOT BE RELEASED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED WITH SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758512 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY THE COATING FROM THE JAWS HAS DETACHED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711157 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISPOSABLE STOPS WORKING BECAUSE PART OF THE JAW IS BROKEN. COMMUNICATED TO COORDINATION AND GIVEN A NEW ENERGY CLAMP TO THE DOCTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605357 ↗
• MalfunctionDec 4, 2023Communication or Transmission Problem; Difficult to Open or Close; Communication or Transmission Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE PRODUCT WOULD NOT REGISTER TO THE GEN11 AND THE JAWS WOULD NOT OPEN. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255582 ↗
• MalfunctionNov 20, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC UROLOGICAL PROCEDURE, THE DEVICE BECAME NOT TO BE ENERGIZED AFTER 10 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 18172461 ↗
• MalfunctionOct 25, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A COLOSTOMY THE DEVICE'S JAW IS LOCKED AND DOES NOT ALLOW OPENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004805 ↗
• MalfunctionOct 4, 2023Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT DOES NOT OPEN THE CLAMP CORRECTLY, AS IF THEY WILL STICK. HE TRIES TO WORK WITH THE TWEEZERS AND AFTER 5 MINUTES, IT STAYS COMPLETELY STUCK, AND HE TAKES OUT THE TWEEZERS AND TRIES TO OPEN THEM AND SUCCEEDS. SUBSEQUENTLY, THEY REPORT THAT THEY NO LONGER OPEN AGAIN AND A LEGEND "REPLACE PRODUCT" APPEARS ON THE CONSOLE, TO WHICH ANOTHER ONE IS PROVIDED NEW CALIPER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868567 ↗
• MalfunctionSep 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COLECTOMY THE DOCTOR USED THE DEVICE AND THE SILICONE WAS REMOVED FROM THE JAW. SO IT HAD TO BE REPLACED WITH A NEW ONE. THE DEFECTIVE PRODUCT WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802162 ↗
• MalfunctionAug 29, 2023Material Separation; Detachment of Device or Device Component; Noise, Audible; Material Separation; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC HYSTERECTOMY, AN UNEXPECTED SOUND WAS HEARD, AND THE TIP OF DEVICE WAS BROKEN. THE ELECTRODE PEELED OFF, BUT NO PIECES 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 17643348 ↗
• MalfunctionAug 25, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROSTATECTOMY THE SURGEON WAS TAKING A LOT OF TISSUE INSIDE THE JAWS FROM THE BEGINNING. HE IS MADE TO NOTICE THAT THIS CAN CAUSE THE JAW TO BREAK, WHICH HE ATTENDS TO BUT AFTER 15 MINUTES HE COMMENTS THAT HE IS WASTING A LOT OF TIME AND WHEN TAKING A LOT OF TISSUE AGAIN IT BREAKS THE JAW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624764 ↗
• MalfunctionAug 8, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP MYOMECTOMY THE SURGEON FOUND OUT THAT HE WAS UNABLE TO CLOSE THE JAW WHEN HE TRIED TO GRASP THE TISSUE. THE SURGERY JUST STARTED AND HE ONLY USED IT FOR DISSECTION ABOUT 2 -3 TIMES BEFORE THE INCIDENT HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482508 ↗
• MalfunctionJul 14, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A NEPHRECTOMY THE DOCTOR USED THE INSTRUMENT AND IT WAS NOTICED THAT THE TISSUE IS VERY THICK. THE DOCTOR TOOK TOO MUCH TISSUE, HE IS TOLD THAT IF IT IS POSSIBLE TO TAKE LESS TISSUE SINCE THE JAW CAN BREAK. THE UPSET DOCTOR DOES NOT COMPLY WITH THIS INDICATION AND ENDS UP BREAKING THE JAW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324106 ↗