Enseal ETRIO335HRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705036000297), received between Dec 20, 2017 and May 22, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING THE OB-GYN SURGERY, THE JAWS DID NOT OPEN WHEN THE DEVICE CLAMPED THE TISSUES. NO PIECES WERE 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 22070543 ↗
• MalfunctionApr 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING UROLOGICAL PROCEDURE, THE ACTIVATION BUTTON WAS TOO STIFF TO PRESS. 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 16673653 ↗
• MalfunctionMar 17, 2023Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT WILL NOT OPEN AND CLOSE. INSIDE CAME OUT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564120 ↗
• MalfunctionMar 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TRIGGER WAS STIFF DURING USE. THE DEVICE DIDN¿T CLAMP ANY HARD OBJECTS. 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 16548446 ↗
• MalfunctionJun 1, 2022Difficult to Open or Close; Difficult to Open or Close

  SEE ATTACHED MEDWATCH REPORT NUMBER MW5109014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14564331 ↗
• MalfunctionMay 23, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE LAP TOTAL HYSTERECTOMY, THE JAW MALFUNCTIONED AND GOT STUCK OPENED INSIDE THE PATIENT. TO REMOVED THE ENSEAL, THEY PULLED THE TROCAR OUT OF THE PATIENT AND USED A NEW DEVICE TO COMPLETE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14476703 ↗
• MalfunctionApr 14, 2022Difficult to Open or Close

  ENSEAL TRIO DEVICE FAILED TO OPEN JAWS TO SEAL TISSUE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14117753 ↗
• MalfunctionFeb 8, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, JUST OUT OF THE BOX, THE JAWS WOULDN¿T OPEN AND CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480538 ↗
• MalfunctionJan 4, 2022Therapeutic or Diagnostic Output Failure

  ENSEAL NOT WORKING DURING ACTIVATION. ENSEAL MACHINE READ "REPLACE DEVICE". FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13168975 ↗
• MalfunctionDec 3, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE JAWS BECAME NOT TO OPEN DURING THE DISSECTION. THE HANDLE WAS OPENED BY HAND. THERE IS A POSSIBILITY THAT THE TARGET TISSUE WAS THICK. 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 12925746 ↗
• MalfunctionNov 16, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A NURSE REPORTED THAT THE JAWS COULDN'T BE OPENED DURING PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820339 ↗
• MalfunctionJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LAPAROSCOPIC HYSTERECTOMY THE ENSEAL TRIO WAS USED. WHEN TAKING A BITE OF THICK TISSUE, THE BOTTOM JAW OF THE ENSEAL TRIO BROKE OFF INTO PATIENT. THERE WERE NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172474 ↗
• MalfunctionMay 17, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A SETUP FOR A UROLOGY PROCEDURE THE STAFF NOTICED THAT THE BLISTER PACK WAS ALREADY OPENED AND THEY WERE CONCERNED ABOUT THE STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833840 ↗
• MalfunctionFeb 24, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE THAT THE ENSEAL DEVICE WOULD NOT SEAL OR CUT TISSUE. NO ERROR CODES WERE DISPLAYED ON THE GENERATOR. A HARMONIC 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 11372745 ↗
• MalfunctionFeb 2, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE THAT THE ENSEAL MALFUNCTION AND JAWS HAD TO BE PRIED APART TO BE RELEASED DURING A CASE. PATIENT CONSEQUENCES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265767 ↗
• MalfunctionNov 20, 2020Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY, THE PRODUCT KEPT GIVING THE MESSAGE REPOSITION JAWS AND TRY AGAIN. HANDLE FOR JAWS WOULDN'T CLOSE. OPENED A HARMONIC TO COMPLETE THE CASE. IT IS UNKNOWN IF THERE WERE ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10874988 ↗
• MalfunctionNov 17, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, AN ERROR SOUND WAS HEARD 3 TIMES, AND ¿REPLACE INSTRUMENT¿ WAS DISPLAYED DURING USE. THE DEVICE WAS RECONNECTED, BUT THE ISSUE DID NOT IMPROVE. THE DEVICE WAS USED ON THE THIN ADHESION TISSUE. THE DEVICE DID NOT CLAMP THE METAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10852073 ↗
• MalfunctionSep 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, ON THE FIRST DEVICE, IT WAS FOUND THAT THE LOWER JAW PROTRUDED WHEN THE NURSE RECEIVED THE DEVICE DURING THE OPERATION. THE DEVICE WAS REPLACED, BUT THE INNER CYLINDER CAME OUT FROM THE DEVICE WHEN THE NURSE WAS CLEANING THE JAWS WITH THE GAUZE. THE DEVICE WAS USED AROUND THE KIDNEY. NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. ONE DEVICE¿S CORD HAD BEEN CUT BECAUSE THE CONNECTION PART DID NOT COME OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542113 ↗
• MalfunctionSep 16, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE JAWS WOULD NOT OPEN WHEN THE HANDLE WAS RELEASED. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10540948 ↗
• MalfunctionAug 26, 2020Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A UROLOGY SURGERY, THERE WAS A PROBLEM ON THE GRIP OF THE DEVICE AND THE JAWS DID NOT OPEN AND CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10456362 ↗
• MalfunctionMay 15, 2020Mechanical Jam

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, THE SURGEON CLOSED THE JAWS OUTSIDE THE PATIENT'S BODY, THE HANDLE GOT STUCK AND THE JAWS LOCKED. THE BLADE TIP WAS NOT BROKEN OFF AND 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 Consequences Or Impact To Patient

  MAUDE report 10062503 ↗
• MalfunctionFeb 6, 2020Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY, THE JAWS BECAME NOT TO OPEN AND CLOSE DURING USE. THE JAWS WERE LOOSE. RF60 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679136 ↗
• MalfunctionOct 25, 2019Failure to Auto Stop

  IT WAS REPORTED THAT DURING A LAP VENTRAL HERNIA, THE DEVICE CONTINUED TO FIRE AND ACTIVATE AFTER THE BUTTON WAS RELEASED. 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 9241887 ↗
• MalfunctionOct 15, 2019Difficult to Open or Close

  DURING AN EXPLORATORY LAPAROSCOPY, RESECTION OF SIGMOID COLON, DRAINAGE OF PELVIC ABSCESS, COLOSTOMY, THE ENSEAL DEVICE MALFUNCTIONED. THE UPPER JAW WOULD NOT CLOSE. IT HAD BEEN WORKING THEN IT STOPPED. THE UPPER JAW WOULDN'T COME DOWN. IT STAYED IN THE UP POSITION AND COULD ONLY CLOSE WITH FORCE ONCE REMOVED FROM THE TROCAR. A NEW DEVICE WAS OBTAINED AND FUNCTIONED PROPERLY. THE DEVICE WAS NOT SAVED. NO HARM CAME TO THE PATIENT.

  Patient problems: Abscess

  MAUDE report 9192543 ↗
• MalfunctionJun 27, 2019Difficult to Open or Close

  IT WAS REPORTED THAT THE JAW OPENING OF ENSEAL WAS NOT SMOOTH AND IT WAS DIFFICULT TO FULLY OPEN THE JAW. THE SURGERY FINALLY COMPLETED BY ANOTHER NEW ENSEAL. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740994 ↗