Enseal NSLG2S45Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705036014195), received between Mar 15, 2018 and Jun 21, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE DEVICE HAD ISSUES. DURING ACTIVATION ONE OF THE COPPER JOINTS OF THE DEVICE CAME OUT AND WAS DANGLING. WHEN IT WENT TO FIRE THE BLADE AUTOMATICALLY STOPPED AND WOULD NOT ADVANCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580227 ↗
• MalfunctionSep 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY THE PRODUCT WAS BROKEN DURING THE PROCESS AND THE TIP FELL INTO THE PATIENT. IT DID NOT CAUSE ANY NEGATIVE RESULTS IN THE PATIENT. THE PROCESSING TIME HAS EXTENDED AS MUCH AS THE TIME TAKEN TO REPLACE THE PRODUCT WITH A NEW ONE AND REMOVE THE BROKEN TIP. THE GENERAL CONDITION OF THE PATIENTS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403367 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY THE PRODUCT WAS BROKEN DURING THE PROCESS AND THE TIP FELL INTO THE PATIENT. IT DID NOT CAUSE ANY NEGATIVE RESULTS IN THE PATIENT. THE PROCESSING TIME HAS EXTENDED AS MUCH AS THE TIME TAKEN TO REPLACE THE PRODUCT WITH A NEW ONE AND REMOVE THE BROKEN TIP. THE GENERAL CONDITION OF THE PATIENTS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314369 ↗
• MalfunctionJul 14, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SLEEVE GASTRECTOMY PROCEDURE, THE JAW BROKE OFF OF THE ENSEAL. A LIKED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019535 ↗
• MalfunctionJul 14, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING SLEEVE GASTRECTOMY PROCEDURE THE JAW WAS LOOSE. A LIKED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15017761 ↗
• MalfunctionOct 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585772 ↗
• MalfunctionOct 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585712 ↗
• MalfunctionOct 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585606 ↗
• MalfunctionOct 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585387 ↗
• MalfunctionOct 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585130 ↗
• MalfunctionAug 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LOT MISMATCH BETWEEN THE OUTER BOX WHICH REPORTS R93P1K (EXP. 31/5/23) AND THE INNER BOX WHICH REPORTS R93G48 (EXP. 30/4/23).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374577 ↗
• MalfunctionJul 27, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE GEN11 DISPLAYED A WARNING MESSAGE TO CHANGE THE INSTRUMENT. THE INSTRUMENT DIDN'T ACTIVATE ANYMORE. THEY HAD TO TAKE ANOTHER SAME LIKE DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233681 ↗
• MalfunctionMar 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLECTOMY, THE JAWS OF THE DEVICE WOULD NOT CLOSE COMPLETELY, AND THE TIP OF THE JAW BROKE OFF AND FELL INTO THE PATIENT. THE TIP WAS FOUND AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851110 ↗
• MalfunctionFeb 19, 2019Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THEY ARE RECEIVING THE ERROR CODE MULTIPLE TIMES AND THEY ARE SWITCHING THEM OUT. ENSEALG2. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352302 ↗
• MalfunctionFeb 7, 2019Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THEY ARE RECEIVING THE ERROR CODE MULTIPLE TIMES AND THEY ARE SWITCHING THEM OUT. "ENSEALG2". CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318872 ↗
• MalfunctionOct 29, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING A GYN EXPLORATORY LAPAROSCOPY PROCEDURE THE ENSEAL DEVICE WHEN CLOSED WOULD NOT RELEASE VERY WELL (JAM AND HARD TO OPEN). A SECOND DEVICE WITH SAME LOT NUMBER WAS OPENED AND SAME ISSUE HOWEVER THIS TIME A BLACK THIN PIECE OF METAL (OR WIRE) CAME OUT OF THE JAWS. NO PATIENT COMPLICATIONS REPORTED. USED A KLEPPINGER TO SEAL TISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8016972 ↗
• MalfunctionOct 29, 2018Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A GYN EXPLORATORY LAPAROSCOPY PROCEDURE THE ENSEAL DEVICE WHEN CLOSED WOULD NOT RELEASE VERY WELL (JAM AND HARD TO OPEN). A SECOND DEVICE WITH SAME LOT NUMBER WAS OPENED AND SAME ISSUE HOWEVER THIS TIME A BLACK THIN PIECE OF METAL (OR WIRE) CAME OUT OF THE JAWS. NO PATIENT COMPLICATIONS REPORTED. USED A KLEPPINGER TO SEAL TISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015282 ↗
• MalfunctionJun 22, 2018Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLOSTOMY TAKE-DOWN THE ENSEAL DEVICE WAS NOT CUTTING THROUGH THE TISSUE AND THE JAW BROKE. ANOTHER ENSEAL DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629744 ↗
• MalfunctionMar 15, 2018Sticking

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE DEVICE WAS CLAMPING AND ACTIVATING WITH NO PROBLEMS AND AT SOME POINT, IN THE PROCEDURE THE JAWS STARTED STICKING WHEN THE JAWS WERE CLOSED. A SECOND LIKE DEVICE WAS TRIED AND AFTER A SHORT TIME THE JAWS STARTED STICKING ON THIS DEVICE. A THIRD LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342359 ↗
• MalfunctionMar 15, 2018Sticking

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE DEVICE WAS CLAMPING AND ACTIVATING WITH NO PROBLEMS AND AT SOME POINT, IN THE PROCEDURE THE JAWS STARTED STICKING WHEN THE JAWS WERE CLOSED. A SECOND LIKE DEVICE WAS TRIED AND AFTER A SHORT TIME THE JAWS STARTED STICKING ON THIS DEVICE. A THIRD LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7342279 ↗