Enseal NSLG2S35Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10705036014188), received between Nov 30, 2017 and Dec 15, 2023 — classified as 2 injuries, 143 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN PROSTATECTOMY THE BRANCH BROKE OFF. THE DURATION OF THE OPERATION IS NO MORE THAN 60 MINUTES. THE PATIENT WAS NOT INJURED. THE OPERATION WAS COMPLETED WITHOUT THE USE OF ELECTROSURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334137 ↗
• MalfunctionNov 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COLOSTOMY, WHEN USING THE DEVICE, THE DOCTOR INDICATES THAT IT MAKES IT DIFFICULT TO CLOSE THE JAW AND PRESS TO ACTIVATE. SHEN TRYING, THE JAW BREAKS, LEAVING IN SEVERAL PIECES. IT ALSO REFERS, THAT IT WAS NOT A THICK TISSUE, INDICATES THAT IT WAS A SUITABLE TISSUE, WHERE IT HAD USED REPEATEDLY THIS DEVICE. REMOVE PARTS AND CONTINUE WITHOUT ADVANCED ENERGY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241763 ↗
• MalfunctionNov 10, 2023Failure to Read Input Signal; Material Integrity Problem; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT WORK DURING THE OVARIAN TUMOR RESECTION PROCEDURE. IT WAS DISCONNECTED AND CONNECTED REPEATEDLY. THE CONSOLE INDICATED ITS FAILURE. PROCEED TO CHECK THE DEVICE AND ONE OF ITS TIPS WAS LOOSE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112676 ↗
• MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT DURING THE INTERVENTION. NO PATIENT IMPACT. THE BROKEN PART WAS RETRIEVED. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958191 ↗
• MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTERECTOMY THE UPPER JAW BROKEN DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642275 ↗
• MalfunctionAug 1, 2023Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A LASH, VERY SHORTLY AFTER USING THE SCISSORS, THE SURGEON NOTICED A SQUEAKING NOISE. AFTER PULLING THE DEVICE OUT OF THE TROCAR, THE UPPER JAW BROKE OFF. NO PATIENT HARM, NO PARTS REMAIN IN PATIENT. A NEW PAIR OF SCISSORS WAS OPENED AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436599 ↗
• MalfunctionJul 7, 2023Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE THE DEVICE WAS STUCK ON TISSUE. CUSTOMER DISSECTED AROUND DEVISE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278778 ↗
• MalfunctionJul 7, 2023Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE DEVICE JAWS WERE CLOSED THEY WOULD NOT REOPEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278541 ↗
• MalfunctionJul 7, 2023Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE DEVICE JAWS WERE CLOSED THEY WOULD NOT REOPEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278467 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN CLOSED THE JAWS AND ACTIVATED THE DEVICE ON THICK TISSUE, THE JAWS BROKE AND A PIECE FELL INSIDE THE PATIENT. ACCORDING TO THE SURGEON, ALL PARTS WERE FOUND AND REMOVED FROM THE PATIENT THE SURGERY WAS DELAYED 5 MINUTES BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261557 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074043 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073850 ↗
• MalfunctionJun 2, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054326 ↗
• MalfunctionJun 2, 2023Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17053603 ↗
• MalfunctionJun 2, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE THE DEVICE WAS NOT SEALING PROPERLY AND IT WAS DIFFICULT TO CLOSE. THE ONE SIDE OF THE JAW EVENTUALLY BROKE OFF. THE FRAGMENTS WERE RETRIEVED. THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050064 ↗
• MalfunctionFeb 2, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY AT THE TIME OF TAKING TISSUE IN THE DEVICE DOES NOT START THE ENERGY CYCLE. THE DEVICE IS DISCONNECTED FOR A POSSIBLE FAILURE, IT IS RECONNECTED AND IT CONTINUES TO SHOW THE SAME ERROR. DOCTOR REQUESTS THE CHANGE OF THE CLAMP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286076 ↗
• MalfunctionDec 20, 2022Device Alarm System; Failure to Read Input Signal; Material Integrity Problem; Device Alarm System; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT DURING A OOPHORECTOMY THE DOCTOR USES NSLG2S35 DURING THE PROCEDURE. THE DOCTOR OCCUPIES THE CLAMP WITHOUT ANY PROBLEM AT THE BEGINNING OF SURGERIES AND DURING THE PROCEDURE IT BEGAN TO MARK THAT THE CLAMP WAS OPENED, LATER IT TELLS ME TO CHANGE THE DEVICE AND THE NURSE COMMENTS THAT THE BLADE CAME OFF. CHANGED THE CLAMP TO CONTINUE WITH THE PROCESS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013476 ↗
• MalfunctionNov 21, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE TOTAL LAP HYSTERECTOMY PROCEDURE WHEN THE DOCTOR WAS DIVIDING AND SEALING THE UTERINE ARTERY, THE DEVICE LOCKED UP AND WOULD NOT OPEN. THEY CLAIM IT WAS BROKEN AND THEY HAD FORCE IT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835376 ↗
• MalfunctionNov 21, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE TOTAL LAP HYSTERECTOMY PROCEDURE WHEN THE DOCTOR WAS DIVIDING AND SEALING THE UTERINE ARTERY, THE DEVICE LOCKED ON AND WOULD NOT OPEN. THEY CLAIM IT WAS BROKEN AND THEY HAD FORCE IT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM THAT WE ARE AWARE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834416 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PANPROCTOCOLECTOMY THE TIP CAME OFF BUT ALL THE BITS WERE RETRIEVED FROM THE PATIENT. A NEW DEVICE WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736371 ↗
• MalfunctionOct 28, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS LOCKED UP AND WOULDN T OPEN. THEY WERE ABLE TO FREE THEM WITH OTHER INSTRUMENTS. ANOTHER DEVICE OPENED AND WAS ABLE TO COMPLETE THE CASE WITH NO COMPLICATIONS TO THE PATIENT. THE SURGERY WAS DELAYED BUT IT WAS LESS THAN 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692324 ↗
• MalfunctionOct 14, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING A TLDG PROCEDURE, THE ERROR MESSAGE "REPLACE INSTRUMENT" OCCURRED. AFTER SWITCHING TO A NEW ONE, THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605137 ↗
• MalfunctionSep 13, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SIGMOIDECTOMY THE DOCTOR FELT RESISTANCE IN THE DEVICE AND THE DEVICE GOT STUCK. IT WOULD NOT CLOSE THE JAW. THE DOCTOR REQUESTED THAT THE DEVICE BE CHANGED AND THE SURGERY CONTINUED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415304 ↗
• MalfunctionAug 23, 2022Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING LAP HYSTERECTOMY, AS THEY WERE TRYING TO GRAFT THE TISSUE TO SEAL IT THEY EXPERIENCED LOCKING OF THE JAWS AND EVENTUAL BREAKAGE AT THE JAW. CASE COMPLETED WITH A MEDTRONIC DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277821 ↗
• MalfunctionAug 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON LOST ONE OF THE JAWS INSIDE THE PATIENT, BUT MANAGED TO EXTRACT THEM FROM THE PATIENT. THE SURGERY WAS DELAYED BUT THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265716 ↗