Enseal NSLG2C25Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705036014133), received between Jan 12, 2018 and Mar 26, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROSTATECTOMY THE DEVICE DID NOT OPEN. ALERT MESSAGE REPLACE INSTRUMENT WAS DISPLAYED. NO AE REPORTED. DEVICE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699517 ↗
• MalfunctionJun 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE LITTLE METALLIC PIECE AT THE DEVICE'S TIP USED TO HOLD THE BLADE BROKE. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621009 ↗
• MalfunctionMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A BREAKAGE OF THE TIP OF THE JAW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902894 ↗
• MalfunctionMar 13, 2024Difficult or Delayed Activation; Difficult to Open or Close; Difficult or Delayed Activation; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW IS NOT WORKING & MOVING FREELY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896939 ↗
• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING A PROSTATECTOMY, DURING USE, A METALLIC COMPONENT DETACHED FROM THE TIP. PIECE RETRIEVED. DEVICE REPLACED. NO AE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675362 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911708 ↗
• MalfunctionApr 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE JAWS JAMMED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822877 ↗
• MalfunctionApr 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE JAWS JAMMED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822846 ↗
• MalfunctionApr 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE JAWS JAMMED SHUT AFTER FIVE MINUTES. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822819 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem; Detachment of Device or Device Component; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE BROKEN DURING NORMAL USE. USE OF ANOTHER DEVICE TO FINISH THE PROCEDURE. NO ADDITIONAL BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114380 ↗
• MalfunctionNov 8, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CUSTOMER PLUGGED IN DEVICE TO GEN11. THE READY SIGNED WAS VIEWED. WHEN SURGEON TRIED TO DELIVER ENERGY, NOTHING HAPPENED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755213 ↗
• MalfunctionAug 16, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PELVIC DISSECTION, THE DEVICE LOCKED AND IT COULD NO LONGER CLOSE TO ACTIVATE THE COAGULATION AND CUTTING MECHANISM. SO ANOTHER DEVICE WAS USED TO PROCEED WITH THE SURGERY. THERE WERE NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235309 ↗
• MalfunctionJun 29, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A LAP PROSTATECTOMY THE EXISTING POLYPROPYLENE MESH WAS LAPAROSCOPICALLY CUT AT 4 POINTS AFTER ABDOMINAL WALL HERNIA. AFTERWARDS NO MORE FUNCTION OF THE SCISSORS. NO PATIENT HARM REPORTED NOR SURGICAL DELAY. SURGERY CONTINUED WITH SAME LIKE SCISSORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859980 ↗
• MalfunctionMay 9, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC RESPIRATORY SURGERY, THE BLADE BECAME NOT TO MOVE FORWARD, AND THE JAWS BECAME NOT TO OPEN/CLOSE WHEN CUTTING THE MUSCULAR COAT. THE DEVICE WAS USED FOR TWO TIMES. 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 14342936 ↗
• MalfunctionJan 26, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN ABDOMINAL HYSTERECTOMY THE JAWS OF THE DEVICE WOULD NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358344 ↗
• MalfunctionNov 2, 2021Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE THAT THE DEVICE ¿JAWS WOULD NOT OPEN UP, IT BROKE¿. 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 12738212 ↗
• MalfunctionSep 22, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT, DURING AN OPEN HEPATECTOMY, THE DEVICE DID NOT REACT WHEN THE SURGEON TRIED TO PERFORM THE SEALING. THE ACTIVATION SOUND WAS NOT HEARD. 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 12511920 ↗
• MalfunctionAug 31, 2021Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE RETRO PERITONEAL RESECTION PROCEDURE BY SURGEON A NEW 25 CM CURVED TIP FORCEPS WAS OPENED TO USE. IN THE PROCEDURE. IT WORKED WITH AROUND 3 - 4 ACTIVATIONS OF NORMAL ENERGY. BUT WHEN THE JAWS WERE ACTIVATED AGAIN, THEY NO LONGER OPENED, APPARENTLY THE JAWS AND THE BLADE WERE LOCKED, THEY WERE TREATED UNTIL THEY COULD BE OPENED BUT LATER THEY NO LONGER WANTED TO CLOSE AND A PART OF THE UPPER JAW WAS THRONE. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391514 ↗
• MalfunctionApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OPEN UROLOGICAL SURGERY, THE TIP OF THE JAWS BROKE WHEN CLEANING. 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 11627497 ↗
• MalfunctionMar 8, 2021Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PARTIAL HEPATECTOMY, THE HANDLE WAS STIFF AND BECAME NOT TO CLOSE THE JAWS. 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 11435020 ↗
• MalfunctionNov 2, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY THE ENSEAL JAWS DID NOT CLOSE AND DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10770654 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Positioning; Material Integrity Problem; Difficult or Delayed Positioning; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE BLADE OF THE ENSEAL DEVICE WENT FORWARD, IT DID NOT COME BACK AND STUCK IN THE BLADE RAIL. IT SEEMED TO BE BROKEN OFF. THE SURGEON TOOK THE DEVICE OUT FROM A PATIENT. A SCRUB NURSE CLEANED THE JAW AND SEEMED TO SEE THE PART OF THE BLADE. THE PATIENT HAD AN X-RAY TEST, BUT THERE APPEARED TO BE NO FRAGMENTS IN THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693210 ↗
• MalfunctionSep 9, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN HEPATECTOMY, THE JAWS BECAME NOT TO OPEN AND CLOSE DURING USE. THE DEVICE DID NOT CLAMP THE THICK TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10507188 ↗
• MalfunctionAug 6, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN OPEN PANCREATICODUODENECTOMY, IN THE MIDDLE OF THE OPERATION, THE JAWS BECAME LOOSE. THE JAWS COULD NOT BE OPENED OR CLOSED. THE DEVICE HAD CLAMPED THICK TISSUE SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10374996 ↗
• MalfunctionJul 29, 2020Material Separation; Ambient Noise Problem; Difficult to Open or Close; Material Integrity Problem; Material Separation; Ambient Noise Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING SEMI-OPEN PNEUMONECTOMY, AT THE THIRD OR FOURTH USE DURING A CHEST WALL (MUSCLE) INCISION, THERE WAS AN ABNORMAL CLICKING SOUND AND THE JAW NO LONGER OPENED OR CLOSED. THE JAW WAS EASILY OPENED MANUALLY AND REMOVED FROM THE TISSUE WITHOUT ANY TISSUE DAMAGE. THE BLADE BROKE OUTSIDE THE SURGICAL FIELD AND THE BROKEN PIECE WAS DISCARDED. AS A PRECAUTION, AN X-RAY WAS PERFORMED AFTER THE OPERATION, BUT THERE WERE NO BLADE FOUND IN THE PATIENT'S BODY. WHEN THE PRODUCT WAS USED SEVERAL TIMES, THE JAW OPENED AND CLOSED POORLY AND THE PRODUCT WAS DISCONTINUED AND RETURNED TO THE NURSE. BEFORE A THORACOTOMY, WHEN THE TIP OF THE JAW WAS WIPED WITH GAUZE, THE GAUZE WAS CAUGHT AND THE NURSE TRIED TO FORCE IT, BUT THE TIP BROKE. 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 Consequences Or Impact To Patient

  MAUDE report 10339343 ↗