EEA TRIEEAXL25XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521593114), received between Apr 7, 2026 and Sep 18, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829223 ↗
• MalfunctionSep 15, 2026Failure to Fire

  It was reported that during an end-to-end anastomosis procedure, the instrument did not fire. The device was replaced with a new device to complete the procedure. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766507 ↗
• MalfunctionAug 5, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136935 ↗
• MalfunctionMay 1, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING ROUX EN Y PROCEDURE USING THE CIRCULAR STAPLER, THE TROCAR TIP FELL OFF THE ANVIL WHILE BEING PASSED THROUGH THE GASTRIC TISSUE, AND THE SURGICAL TEAM HAD TO LOCATE THE TROCAR TIP AND RETRIEVED BY USING ANOTHER BAG. IT WAS ALSO NOTED THAT THE SURGICAL TIME WAS EXTENDED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054844 ↗
• MalfunctionApr 21, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE TROCAR TIP CAME OFF WHILE PUNCTURING THROUGH GASTRIC TISSUE. THE SURGICAL TIME WAS EXTENDED FOR LESS THAN 30 MINUTES WHILE THE DETACHED TROCAR TIP WAS LOCATED, AND REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946262 ↗
• InjuryApr 21, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC ROUX-EN-Y REVISION, DURING PLACEMENT OF THE ANVIL THROUGH THE STOMACH, THE TROCAR TIP FELL OFF INTO THE BODY CAVITY WHILE TRYING TO PIERCE THE TISSUE. THE CASE WAS DELAYED AS X-RAY WAS DONE TO LOCATE AND REMOVE THE DEVICE WITH SPECIMEN BAG. THE CURRENT STAPLER WAS THEN USED TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24945926 ↗
• MalfunctionApr 13, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE IN A PATIENT WITH A HISTORY OF OBESITY, THERE WAS A PROCEDURAL IRREGULARITY WHEN REMOVING THE TROCAR TIP FROM THE ANVIL, AS THE SURGEON COMMENTED THAT THE WHITE TROCAR TIP WAS REMOVED MUCH EASIER. NO INTERVENTION WAS DONE OR REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853760 ↗
• MalfunctionApr 7, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING CREATION OF THE ANASTOMOSIS, THE CIRCULAR STAPLER CUT BUT THE STAPLES DID NOT DEPLOY. THE SURGEON MANUALLY SUTURED THE ANASTOMOSIS, AND THE SURGICAL TIME WAS EXTENDED BY ONE HOUR.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 24798987 ↗