Enseal NSEAL535RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705036000044), received between Dec 18, 2017 and Oct 10, 2024 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ILEOCYSTECTOMY PROCEDURE THAT THE TIP OF THE DEVICE BROKE AND FELL OFF DURING USE LAPAROSCOPICALLY. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415969 ↗
• MalfunctionOct 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE THAT THE GENERATOR DID NOT GIVE A SOUND WHEN THE DEVICE WAS DONE SEALING. 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 17875723 ↗
• MalfunctionMar 21, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOTHING AND THE GENERATOR SAID 'READY.' THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581861 ↗
• MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THAT THE TIP BROKE AND DETACHED FROM THE DEVICE. UNKNOWN IF THE FRAGMENT WAS FOUND. 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 16286145 ↗
• InjuryNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT HAD A RETAINED OBJECT FROM AN UNKNOWN PROCEDURE IN 2016. IT WAS DETERMINED THAT THE RETAINED OBJECT WAS THE MOBILE JAW FROM A LAPAROSCOPIC DEVICE. DOCTOR STATES THAT SHE WAS UNAWARE OF THE JAW HAVING BROKEN OFF AT THE TIME OF THE PROCEDURE. THERE WERE PATIENT CONSEQUENCES. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15794057 ↗
• MalfunctionJun 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAP COLECTOMY, SURGEON WAS USING THE ENSEAL DURING THE COLON RESECTION PORTION WHEN THE TIP OF THE DEVICE BROKE OFF. SURGEON NOTICED DEVICE FAILURE AND RETRIEVED THE TIP PORTION OF THE DEVICE. DEVICE WAS REMOVED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14573065 ↗
• MalfunctionOct 29, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION WITH ABDOMINAL HYSTERECTOMY PROCEDURE, THE DEVICE WAS NOT OPENING/CLOSING AND GETTING LOCKED IN POSITION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723809 ↗
• MalfunctionJul 31, 2021Failure to Read Input Signal; Difficult to Open or Close; Failure to Read Input Signal; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE DEVICE WAS ACTIVATED AND RAN THE JAWS TO THE END. THEN THE JAWS BECAME NOT TO OPEN. ¿REPLACE INSTRUMENT¿ WAS DISPLAYED. THERE WAS AN UNUSUAL FEELING IN GRASPING THE HANDLE BEFORE THE ISSUE OCCUR. THE DEVICE WAS USED ON THE BLOOD VESSELS AND MESENTERY. 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 12257045 ↗
• MalfunctionJun 14, 2021Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PROCTRECTOMY, THE DEVICE WAS ACTIVATED AND RAN THE JAWS TO THE END, BUT THE JAWS BECAME NOT TO OPEN SUDDENLY. THE JAWS WERE OPENED BY HAND. THEN THERE WAS A DIFFICULTY IN OPENING AND CLOSING THE HANDLE. THE DEVICE WAS USED ON THE MESORECTUM DISSECTION. 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 11995339 ↗
• MalfunctionApr 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE GEN11 RECOGNIZED THE DEVICE AND MADE THE 1ST SEAL SUCCESSFULLY. THE SURGEON REPORTED HE FELT SOMETHING BREAK ON THE DEVICE AND THE DEVICE WOULD NOT SEAL SUCCESSFULLY THE 2ND TIME. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732234 ↗
• MalfunctionFeb 24, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLECTOMY THE TIP OF THE DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372644 ↗
• MalfunctionSep 24, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY/BILATERAL OOPHERECTOMY THE JAWS WOULDN'T OPEN. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10582519 ↗
• MalfunctionMar 31, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A COLON RESECTION, ENSEAL WAS NOT SEALING WELL AND THE JAWS WERE NOT OPENING WELL. THE CASE WAS COMPLETED WITH ANOTHER ENSEAL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908297 ↗
• MalfunctionMar 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE TOP JAW WOULDN'T OPEN FULLY. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829041 ↗
• MalfunctionFeb 10, 2020Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE JAWS OF THE ENSEAL INSTRUMENT BROKE DURING USE, FALLING INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688112 ↗
• MalfunctionAug 29, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN COLON PROCEDURE, NSEAL THE LEGACY BLUE ENSEAL, THE JAW "ALL JUST BROKE APART". NO FRAGMENTS LEFT IN THE PATIENT. 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 8946880 ↗
• InjuryJan 3, 2019Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A TOTAL LAPAROSCOPIC HYSTERECTOMY, USING AN ENSEAL DEVICE ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES. THE PATIENT WAS DISCHARGED TWENTY-THREE HOURS LATER. THE PATIENT RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2018 COMPLAINING OF PAIN AND DISCOMFORT IN THE LOWER ABDOMINAL AREA. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED BUT THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 WITH THE SAME PAIN AND DISCOMFORT IN THE LOWER ABDOMINAL AREA AND WAS ADMITTED TO THE HOSPITAL. A CT SCAN WAS PERFORMED AND A POCKET OF AIR WAS DISCOVERED IN THE SMALL BOWEL. THE PATIENT WAS MONITORED OVER THE WEEKEND, ANOTHER CT SCAN WAS PERFORMED ON (B)(6) 2018, AND THE RESULTS WERE UNKNOWN. ON (B)(6) 2018, AN EXPLORATORY LAPAROSCOPY WAS PERFORMED AND THERMAL DAMAGE TO THE ILEUM WAS DISCOVERED. THE DOCTOR PERFORMED A RESECTION OF THE AREA AND CREATED A SINGLE ANASTOMOSIS. THE PATIENT IS CURRENTLY BEING MONITORED. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED.

  Patient problems: Abdominal Pain; Injury; No Code Available; Not Applicable

  MAUDE report 8212381 ↗
• MalfunctionApr 25, 2018Self-Activation or Keying

  IT WAS REPORTED THAT THE DEVICE WAS ACTIVATING ON ITS OWN. NO ONE WAS TOUCHING THE ENERGY BUTTON NOR WAS IT TOUCHING ANYTHING TO ACTIVATE THE ENERGY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7458124 ↗
• MalfunctionMar 20, 2018Break; Component Falling

  IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION PROCEDURE THE TIP OF THE DEVICE BROKE OFF. IT WAS RETRIEVED. (UNKNOWN IF IT FELL INTO THE PATIENT) A LIKE DEVICE OF THE SAME PRODUCT CODE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7354503 ↗
• MalfunctionFeb 22, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS AN UNKNOWN ERROR MESSAGE. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290008 ↗
• MalfunctionJan 25, 2018Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE HANDLE WOULD NOT CLOSE AND OPEN PROPERLY. THE PROCEDURE WAS COMPLETED USING AN I-HOOK ON AN ELECTROSURGERY BOVIE UNIT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7219019 ↗
• MalfunctionDec 18, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC ABDOMINAL COLECTOMY, AFTER USING ON THICK TISSUE, THE JAWS OF THE INSTRUMENT WOULDN'T OPEN. THE DOCTOR HAD TO MANUALLY MANIPULATE THE JAWS WITH HIS HANDS TO OPEN THE JAWS OF THE INSTRUMENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126328 ↗