Enseal NSLG2S25Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705036014126), received between Jan 24, 2018 and Jul 29, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE JAW OF THE DEVICE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649992 ↗
• MalfunctionJun 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE THAT THE DEVICE JAWS BROKE BUT DID NOT DETACH AFTER GOING THROUGH TOUGH TISSUE OR OLD MESH. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602577 ↗
• 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 18334167 ↗
• 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 18334095 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN OPEN PROCEDURE, THE JAWS WERE BROKEN OFF DURING THE INCISION BETWEEN THE INTESTINAL MEMBRANES. THE BROKEN PIECES WERE RETRIEVED, AND NO PIECES FELL INTO THE PATIENT. 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 16112249 ↗
• MalfunctionOct 5, 2022Device Alarm System; Detachment of Device or Device Component; Device Alarm System; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE THE PRODUCT PRESENTED FAILURE AT THE BEGINNING OF USE, THE BLADES SHOULD BE RE POSITIONED, AND LATER, HALFWAY THROUGH THE SURGERY, THE UPPER PART OF THE JAW CAME OFF COMPLETELY, NO FORCE OR PRESSURE WAS APPLIED AND IT CAME OFF COMPLETELY. JUST SEPARATE FROM THE REST OF THE CLAMP. THERE WAS NO DELAY OF SURGERY AND THE PROCEDURE WAS SUCCESSFULLY COMPETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546483 ↗
• MalfunctionJun 15, 2022Device Alarm System; Material Integrity Problem; Device Alarm System; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION ON THE RECTUM OF THE PATIENT THE PIN (GUIDE OF THE KNIFE) AT THE COUNTER BEARING FLIPPED UP. THE GENERATOR GAVE THE ALARM "REPLACE INSTRUMENT." NO PATIENT HARM NOR SIGNIFICANT SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697370 ↗
• MalfunctionJun 15, 2022Device Alarm System; Material Integrity Problem; Device Alarm System; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION ON THE RECTUM OF THE PATIENT THE PIN (GUIDE OF THE KNIFE) AT THE COUNTER BEARING FLIPPED UP. THE GENERATOR GAVE THE ALARM "REPLACE INSTRUMENT." NO PATIENT HARM NOR SIGNIFICANT SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697328 ↗
• MalfunctionJun 15, 2022Device Alarm System; Material Integrity Problem; Device Alarm System; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PREPARATION ON THE RECTUM OF THE PATIENT THE PIN (GUIDE OF THE KNIFE) AT THE COUNTER BEARING FLIPPED UP. THE GENERATOR GAVE THE ALARM "REPLACE INSTRUMENT." NO PATIENT HARM NOR SIGNIFICANT SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697214 ↗
• MalfunctionMay 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC PROCTECTOMY THE JAWS OF THE DEVICE BROKE DUE TO LOCATION ON TISSUE AND FORCE. THE CASE WAS COMPLETED WITH THE SECOND DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14481164 ↗
• MalfunctionMay 16, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GYN PROCEDURE, THE SURGEON USED THE DEVICE WAS USED AND WAS BROKEN. ANOTHER DEVICE WAS USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407232 ↗
• MalfunctionMay 16, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GYNAECOLOGICAL PROCEDURE, THE SURGEON USED THE DEVICE AND AFTER 3 USES IT WAS BROKEN AT THE CONNECTION OF THE JAWS. ANOTHER DEVICE WAS USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407198 ↗
• MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY THE ENSEAL PROBE WAS BROKEN FROM THE JOINT. THE LOT OF STRAIGHT JAW PROBES ARE GETTING BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196744 ↗
• MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL PROCEDURE THE ENSEAL'S JAW BROKE WHEN TAKING THE TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558841 ↗
• MalfunctionOct 26, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MILES SURGERY WITH UTERINE RESECTION, WHEN THE SURGEON SECTIONED THE LEFT PERI-VAGINAL TISSUE, THE ENSEAL DEVICE SUFFERED A FRACTURE OF ITS FORCEPS, RENDERING IT UNUSABLE. THE EVENT GENERATED A FRAGMENT THAT WAS REMOVED IN ITS ENTIRETY. THE EVENT DID NOT CAUSE ANY HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734830 ↗
• MalfunctionMay 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARAUTERINE INTAKE, MORE OR LESS 45 MINUTES INTO SURGERY, A SMALL NOISE OCCURRED AND THEY SAW THAT ONE OF THE BRANCHES OF THE JAW WAS MISSING. THEY LOOKED FOR IT INSIDE THE PATIENT AND FOUND IT AT ONE OF THE EDGES OF THE FIELD. THEY REPORT THAT NOTHING UNUSUAL WAS DONE. UPON REALIZING IT, THEY CONTINUED WITH THE USUAL INSTRUMENTS AND ASKED FOR ANOTHER TO DO THE LYMPHADENECTOMY AND OMENTECTOMY. SURGERY WAS DELAYED 15 MINUTES AND WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED, BUT WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075725 ↗
• MalfunctionFeb 25, 2020Difficult to Remove

  IT WAS REPORTED THAT DURING A MILES RESECTION, THE MOBILE JAW PART IS REMOVED DURING USE. THE SURGERY WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED BUT EASILY REMOVED WITH NO ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750274 ↗
• MalfunctionSep 9, 2019Complete Blockage; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A COLON SURGERY, THE DEVICE FAILS PRESENTING A BLOCKAGE IN THE JAW AND DOES NOT OPEN, THE SURGEON HAD TO USE ELECTRO-SCALPEL TO REMOVE THE FRAGMENT OF TISSUE THAT WAS TRAPPED IN THE JAW, THE GENERATOR ASKED FOR A DEVICE CHANGE. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977116 ↗
• MalfunctionAug 1, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY THE ON THE FIRST ATTEMPT AT USING THE DEVICE THE JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8853338 ↗
• MalfunctionJun 18, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE TIP WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610358 ↗
• MalfunctionMay 24, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ENSEAL TIP WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543072 ↗
• MalfunctionMay 8, 2018Device Stops Intermittently; Device Inoperable; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS ACTIVATED IN SURGERY AND IT WORKED IN THE FIRST TIME BUT WHEN USING IT AGAIN IT WAS NOT RECOGNIZED BY THE GENERATOR AND IT COULD NOT BE USED AGAIN. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496918 ↗
• MalfunctionFeb 12, 2018Break

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE SURGEON WAS USING THE DEVICE TO DISSECT TISSUE WHEN THE TIP BROKE OFF. THE TIP WAS RETRIEVED AND TAKEN OUT OF THE STERILE FIELD ALONG WITH THE DEVICE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265152 ↗
• MalfunctionJan 24, 2018Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7215709 ↗