Enseal NSLG2C35ARecalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 10705036014508), received between Nov 30, 2017 and Jun 22, 2026 — classified as 10 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (48 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 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE METAL OF THE JAWS CAME APART. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576817 ↗
• MalfunctionMar 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT IN THE MIDDLE OF AN UNKNOWN SURGERY, TISSUE IS TRAPPED BETWEEN THE JAWS OF THE DEVICE WITHOUT BEING ABLE TO OPEN AND RELEASE, THE BLADE IS TRAPPED IN THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498372 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP CAME APART FROM SECOND ITEM; NO HARM DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460411 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A NEWLY OPENED (B)(6), PLUGGED IN AS USUAL, AFTER A FEW TIMES OF ACTIVATION, COATING DETACHED. NEED TO REPLACE WITH ANOTHER ENSEAL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839130 ↗
• MalfunctionDec 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE BLADE CAME OFF 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 23805155 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ONE END OF THE SHEATH (CLAMP SIDE) LEFT. THIS INCIDENT HAD NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452938 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING AN ABDOMINAL HYSTERECTOMY (TOTAL) THAT THE JAW BROKE OFF INSIDE THE PATIENT AND THEY FOUND IT. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452142 ↗
• MalfunctionOct 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTERECTOMY A NEWLY OPENED NSLG2C35A, PLUGGED IN AS USUAL, AFTER A FEW TIMES OF ACTIVATION, COATING DETACHED. NEED TO REPLACE WITH ANOTHER ENSEAL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265789 ↗
• MalfunctionAug 18, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY THE SURGEON THAT DURING A HALS SIGMOID COLECTOMY THE JAW OF THE INSTRUMENT DISCONNECTED FROM THE INSTRUMENT SHAFT AND WAS HANGING BY A WIRE. THE SURGEON STATED THAT NO EXCESSIVE FORCE WAS USED ON THE INSTRUMENT. THE PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836118 ↗
• MalfunctionAug 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE MESOSIGMOID THE DEFECT OCCURRED. THE JAW PART CAME LOOSE FROM THE SHAFT. THIS WAS NOT IN A STRONGLY ANGULATED SITUATION. A NEW DEVICE WAS USED. THE PROCEDURE WAS DELAYED BUT COMPLETELY SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750528 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HALS SIGMOID COLECTOMY THE INSTRUMENT BROKE. A PORTION OF THE JAW FELL OFF. THE SURGEON STATED THAT NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS DELAYED BY TEN MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519716 ↗
• MalfunctionJul 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DEVICE CARTON IS OPENED, THE DAMAGED INNER PACKAGING DOES NOT MEET STERILITY REQUIREMENTS. UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519597 ↗
• MalfunctionJul 11, 2025Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE STOP WORKING AND A METAL PIECE FALL OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479623 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPY THE INSULATION OF THE TIP GOT STUCK TO THE TISSUE WHILE IT WAS BURNING AND GOT PULLED OFF.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22394867 ↗
• MalfunctionMay 29, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE JAWS NOT OPENING MID CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107986 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GENERAL SURGERY PROCEDURE THAT AFTER INTRODUCING THE DEVICE INTO THE PATIENT WHEN THE JAWS WERE OPENED THE BLACK COATING BROKE APART INTO THE PATIENT. FRAGMENTS WERE RECOVERED. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872639 ↗
• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AT THE DISTAL PORTION OF THE PRODUCT (ARTICULATION JOINT), A SMALL PORTION OF THE PLASTIC BLACK SEAL OPENED UP/ SCRAPED WHILE IN THE TROCAR. BLACK PAINT FLAKED OFF IN THE PATIENT BUT WAS REMOVED. OPENED UP A NEW DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696351 ↗
• MalfunctionNov 11, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, THE TIP OF THE DEVICE COULD NOT BE OPENED. WHEN THE DEVICE WAS COLLECTED, ITS TIP COULD BE OPENED. 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 20658595 ↗
• MalfunctionOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT DURING A LAP TOTAL HYSTERECTOMY, THE DOCTOR NOTICED THAT THE LOWER PART OF THE JAW WAS NOT ATTACHED TO THE ENSEAL DEVICE. IT WAS DECIDED AS A RESULT AN XRAY WOULD NEED TO BE DONE. ONCE THE XRAY WAS TAKEN THE OBJECT WAS NOTED IN THE UPPER RIGHT QUADRANT, AN ADDITIONAL XRAY WAS TAKEN LATER IN THE LATERAL POSITION. A SECOND ENSEAL DEVICE WAS OPENED TO COMPLETED CASE. NO ADDITIONAL PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481814 ↗
• MalfunctionSep 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NO INFORMATION HAS BEEN PROVIDED FOR WHAT THE ISSUE IS WITH THE PRODUCT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309780 ↗
• MalfunctionJun 21, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GYN PROCEDURE THE JAWS WOULD NOT OPEN BACK UP WHEN TRYING TO SEAL THE VESSEL BUT IT ENDED UP SEALING AND CUTTING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582634 ↗
• MalfunctionJun 21, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A CYSTE LEVER THERE WAS AN ERROR AFTER FIRST ACTIVATION ON THICK HEPATIC CYSTE TISSUE. PROLONGED THE PROCEDURE WITH OTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582576 ↗
• MalfunctionJun 8, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS OPENED, CONNECTED AND USED. FIRST ACTIVATION DEVICE PERFORMED NORMALLY. SECOND ACTIVATION FAILED TO CREATE SURGICAL AFFECT, DESCRIBED AS NO POWER. ANOTHER DEVICE WAS OPENED AND PERFORMED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493088 ↗
• MalfunctionMay 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING BLADDER TOTAL EXTIRPATION, THE DEVICE COULD NOT BE OPENED AFTER THE FIRST SHUTTING OFF. 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 19375781 ↗
• MalfunctionMay 20, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THEY COULDN'T OPEN THE HANDLE/JAWS OF THE DEVICE WHILE ON TISSUE. THE HANDLE WOULDN'T RELEASE AT ALL. THEY WERE ABLE TO GET ANOTHER ONE TO COMPLETE THE REMAINDER OF THE LAPAROSCOPIC HYSTERECTOMY WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353760 ↗