Enseal NSLG2S35ARecalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10705036014515), received between Nov 30, 2017 and Sep 28, 2026 — classified as 3 injuries, 110 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. 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 113 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  It was reported that some of the black insulating material on the shaft of the instrument came off inside the patient during a laparoscopic anterior resection. The surgeon was unable to retrieve the piece of insulation. He does not anticipate that this will cause any issues for the patient.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916529 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL PROSTATECTOMY THERE WAS A MALFUNCTION OF THE ENSEAL TIP, PART OF THE JAW OF THE FORCEPS BROKE. INCREASE IN OPERATING TIME SIGNIFICANT RISK FOR THE PATIENT APPROACH PUT IN PLACE: REMOVAL OF THE MISADAPTED TIP (SURGICAL ADAPTATION TO EXTRACT THE MATERIAL), CHANGE OF FORCEPS (USE OF ANOTHER DEVICE), ADDITIONAL COST FOR THE PROCEDURE, ADDITIONAL OPERATING TIME, CRISIS MANAGEMENT. CURRENT STATE OF THE PATIENT: IMPORTANT CLINICAL RISK IN LAPAROSCOPIC PROCEDURE. NO PATIENT IMPACT BECAUSE REMOVAL OF THE MATERIAL CONCERNED, BUT SURGICAL ADAPTATION TO REMOVE THE MATERIAL ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE MANAGEMENT OF THE PATIENT: REMOVAL OF THE DETACHED PART OF THE JAW; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24966973 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION THAT WHEN CLAMPING THE JAW SNAPPED AND A JAW PIECE WAS BROKEN OFF OF THE DEVICE. THE PIECE WAS RETRIEVED. A SECOND ENSEAL WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692317 ↗
• MalfunctionJul 29, 2025Failure to Read Input Signal; Difficult to Open or Close; Failure to Read Input Signal; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE LOCKED COMPLETELY OUT ON THE TISSUE WITH THE KNIFE BLADE FULLY ADVANCED. DEVICE WOULD NOT ACTIVATE ENERGY, MESSAGING ON THE SCREEN WHEN ATTEMPTING TO ACTIVATE WAS "REPOSITION DEVICE" EVENTUALLY THE SURGEON WAS ABLE TO BREAK THE DEVICE TO GET IT TO RELEASE FROM THE TISSUE. PROCEDURE WAS DELAYED BY 15 MINUTES. PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650133 ↗
• MalfunctionMay 22, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAWS OF IT WILL NOT OPEN AND CLOSE WITH THE HANDLE. SOMETHING CAME BROKEN IN IT. NEW DEVICE WAS OPENED. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073390 ↗
• MalfunctionFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY LEFT SIGMOID PROCEDURE THAT THE "ONE SIDE OF THE SEALER IS MISSING." NO FURTHER DETAILS WERE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332440 ↗
• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE JAW BROKE AT THE BEGINNING OF THE UNKNOWN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324617 ↗
• MalfunctionNov 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAP MILT CYSTE REMOVAL THE CYSTE WAS SURROUNDED BY HARD TISSUE AND THE JAWS OF THE DEVICE SNAPPED TWICE WHILE RESECTING. A NEW DEVICE WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695120 ↗
• MalfunctionNov 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAP MILT CYSTE REMOVAL THE CYSTE WAS SURROUNDED BY HARD TISSUE AND THE JAWS OF THE DEVICE SNAPPED TWICE WHILE RESECTING. A NEW DEVICE WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695030 ↗
• MalfunctionNov 7, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTERECTOMY AT THE TIME OF USE TAKING 2 HOURS OF SURGERY TO RELEASE A PART OF THE JAW, WITHOUT SOME EXTREME USE OR FORCE OF APPLICATION. THE DEVICE IS CHANGED FOR ANOTHER ENSEAL AND THE SURGERY CONTINUED WITHOUT MAJOR PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630044 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT DURING A OB/GYN PROCEDURE, THE JAW FELL OFF. IT LOOKS LIKE THE TOP JAW CAME OFF AND FELL INTO THE PATIENT, THEY WERE ABLE TO RETRIEVE IT. CASE WAS COMPLETED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621501 ↗
• InjuryOct 29, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED, THAT DURING A GYN PROCEDURE, THE DEVICE THEY WERE USING GAVE A WARNING SIGN ON THE GENERATOR TO REPOSITION JAWS AND REACTIVATE. THEY THEN RECEIVED AN ERROR TO REPLACE INSTRUMENT AND INSTRUMENT ERROR DETECTED. OPENED ANOTHER DEVICE FROM THE SAME LOT AND RECEIVED THE SAME THREE ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561383 ↗
• InjuryOct 29, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED, THAT DURING A GYN PROCEDURE, THE DEVICE THEY WERE USING GAVE A WARNING SIGN ON THE GENERATOR TO REPOSITION JAWS AND REACTIVATE. THEY THEN RECEIVED AN ERROR TO REPLACE INSTRUMENT AND INSTRUMENT ERROR DETECTED. OPENED ANOTHER DEVICE FROM THE SAME LOT AND RECEIVED THE SAME THREE ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561013 ↗
• MalfunctionAug 23, 2024Failure to Read Input Signal; Material Integrity Problem; Failure to Read Input Signal; Material Integrity Problem

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY THE TIP IS WEAK AND THE GENERATOR THROWS AN ERROR WHEN THE ENERGY IS CHECKED. IT IS NOTED THAT THE TIP IS FRACTURED. ANOTHER TYPE OF ENERGY IS REQUESTED AND THE CASE IS TERMINATED, IF THERE IS NO RISK TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049694 ↗
• MalfunctionAug 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE NEW ARTICULATED MODEL WHICH DOES NOT OPEN OR CLOSE THE JAW. IT PERFORMS THE MOVEMENT WITH GREAT DIFFICULTY SINCE IT ENTERS THE CAVITY. THE DIFFICULTY IS OBSERVED. THE DR. TRIES TO CUT THE TISSUE BUT SEEING THAT IT IS NOT SAFE TO CLOSE THE JAW REQUEST TO CHANGE THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048720 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY; DEVICE TIP SNAPPED OFF AND BROKE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844067 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A JAW BROKE. OPERATION PROLONGED FOR PATIENT. RECOVERY OF THE MOUTHPIECE TO CHECK ITS COMPLETENESS, REPLACEMENT BY ANOTHER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609901 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PART OF THE JAW ON THE PRODUCT BROKE OFF. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478060 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PTC FELL OFF THE DEVICE WHILE ON THE TABLE. NO PATIENT HARM/INVOLVEMENT REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354298 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139712 ↗
• MalfunctionApr 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CAUTERIZING JAW OF THE DEVICE BROKE OFF IN THE PATIENTS ABDOMEN. FRAGMENT OF THE DEVICE WAS FOUND AND REMOVED. THERE WAS NO MENTION OF THE PATIENT NEEDING AN X-RAY TO FIND THE FRAGMENT. 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 19127854 ↗
• MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE END OF THE ARTICULATING DEVICE FELL OFF. THEY RETRIEVED IT AND OPENED A NEW DEVICE TO CONTINUE WITH THE CASE. THE PROCEDURE WAS DELAYED 5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920458 ↗
• MalfunctionJan 25, 2024

  ENSEAL FAILED TO ARTICULATE OR CLOSE JAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588759 ↗
• MalfunctionDec 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE PROCEDURE, ONE OF THE TWO JAWS BREAKS. ABDOMINAL EXPLORATION TO REMOVE THE BROKEN JAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18292278 ↗
• MalfunctionNov 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAP HYSTERECTOMY, THE DOCTOR WAS IN THE PROCESS OF SURGERY ON A PATIENT AND THE JAW CAME OFF, THEY WERE ABLE TO LOCATE THE PIECE. AN ABDOMINAL X-RAY WAS COMPLETED TO CONFIRM THAT NOTHING ELSE REMAINED WITHIN PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112504 ↗