EEA TRIEEAXL31MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521593145), received between Dec 30, 2021 and Jan 10, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K172361, K221005); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Break; Device Slipped; Failure to Form Staple; Break; Device Slipped; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOW LEFT COLON RESECTION INVOLVING THE CIRCULAR STAPLER, THE SAFETY LEVER OF THE STAPLER WAS BROKEN LIKELY DUE TO INCOMPLETE CLOSING CAUSED BY THE PRESENCE OF EXCESSIVE TISSUE. ALTHOUGH THE BLADE WORKED, BUT THE STITCHES WERE BEING SHOT OPEN, THE STAPLES WERE NOT FORMED B SHAPED BUT A BIT LINEAR. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE. A PROTECTIVE STOMA CREATION WAS NECESSARY. THE SURGICAL TIME WAS EXTENDED FOR ONE HOUR AS A RESULT.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21128392 ↗
• MalfunctionSep 13, 2024Positioning Problem; Incomplete or Inadequate Connection; Positioning Problem; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A COLORECTAL ANASTOMOSIS, WHEN THE SURGEON INSERTED THE DEVICE, THE TIP DID NOT COME OUT OF THE INSTRUMENT. IT WAS NOT POSSIBLE TO CONNECT THE ANVIL OF THE DEVICE. IT WAS NOTED THAT THERE WAS A STRUGGLE TO TURN THE BLACK WING NUT. THE SURGERY WAS EXTENDED BY 10 MINUTES. THE PRODUCT WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217240 ↗
• MalfunctionDec 30, 2021Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC LEFT COLECTOMY, ON INSERTION OF THE ANVIL THROUGH A SMALL INCISION BY THE PHYSICIAN ASSISTANT, THE ANVIL TILTED PREMATURELY. THE SURGEON NOTICED IT ONCE THE ANVIL WAS INSIDE THE ABDOMINAL CAVITY. THE ANVIL WAS THEN REMOVED. A SECOND STAPLER WAS OPENED AND A NEW ANVIL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119502 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172361, K221005. One submission often covers many models, so check the product and lot details in each record.

• Z-0070-2019 · Aug 17, 2018 · Terminated
  EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a