Enseal NSLG2C45Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705036014157), received between May 10, 2018 and Jun 27, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THE PRODUCT RANDOMLY STOPPED WORKING 30 MINUTES INTO THE A CARACSOTHAGEL HERNIA REPAIR. THEY GOT A NEW DEVICE TO COMPLETE THE REST OF THE CASE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624800 ↗
• MalfunctionJul 18, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE THE DEVICE WOULD NOT OPEN OR CLOSE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343835 ↗
• MalfunctionApr 10, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE THAT THE ¿TRIGGER WOULDN¿T FULLY RELEASE WHEN OPERATED¿. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709335 ↗
• MalfunctionFeb 16, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, WHEN THE SURGEON OPENED THE DEVICE AND TRIED TO USE IT, THIS WAS BLOCKED AND THEY COULDN'T OPEN IT. THE DEVICE WASN'T ACTIVATED, SO THERE WAS NO PATIENT ADVERSE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386166 ↗
• MalfunctionOct 17, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JAW WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616101 ↗
• MalfunctionJan 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING KIDNEY AND ADRENAL GLAND PROCEDURE WITH DA VINCI, I-BLADE WAS BROKEN DURING USE. BROKEN PIECE HAS BEEN RETRIEVED. 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 13251912 ↗
• MalfunctionMar 19, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DUODENAL SWITCH THE DEVICE FAILED TO ACTIVATE/MALFUNCTIONED AFTER INITIAL USE. A SECOND DEVICE WAS OPENED AND HAD THE SAME ISSUE. A THIRD DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856952 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE BLOCKED INTRAOPERATIVELY AND THE DEVICE DID NOT CUT. INSTRUMENT COULD BE EASILY OPENED AND REMOVED FROM THE TISSUE. AN ADDITIONAL DEVICE WAS OPENED AND THE OP ENDED WITH NO INFLUENCE ON SURGERY AND PAT. SAFETY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856765 ↗
• MalfunctionAug 2, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AT AN UNKNOWN TIME THE JAWS OF THE DEVICE WOULD NOT OPEN. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855316 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE JAW IS DETACHED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8014736 ↗
• MalfunctionJun 22, 2018Break

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE GRASPING METAL BITS FELL APART WHILE USING INSIDE THE PATIENTS ABDOMEN. THE FALLEN PIECE WAS RETRIEVED. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT. THE PROCEDURE WAS DELAYED 20 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629704 ↗
• InjuryMay 10, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON WAS LOOKING TO TRANSECT THE SHORT GASTRIC ARTERY CLOSE TO THE SPLEEN. THE ENSEAL WAS CLOSED AND ALL TONES WERE HEARD. WHEN THE DEVICE WAS OPENED IT HAD CUT THE VESSEL BUT NOT SEALED IT. A VASCULAR SURGEON WAS CALLED IN TO ASSIST. THE PATIENT WAS OPENED TO CONTROL THE BLEEDING BUT THE PROCEDURE WAS COMPLETED LAPAROSCOPIC. THE PATIENT ENDED UP LOSING LARGE VOLUME OF BLOOD, 3.5 L. THE PATIENT WAS TRANSFERRED TO ICU FOR 24 HRS.

  Patient problems: Blood Loss

  MAUDE report 7503261 ↗