EEA TRIEEA33MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521593060), received between Jun 15, 2023 and May 14, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Failure to Cut

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE FAILED TO CUT; THEREFORE, CONVENTIONAL SURGERY WAS PERFORMED.

  Patient problems: Failure to Anastomose

  MAUDE report 25174816 ↗
• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANVIL PORTION DISENGAGED BEFORE STAPLING. A NEW DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439365 ↗
• MalfunctionOct 19, 2024Break; Failure to Align; Detachment of Device or Device Component; Break; Failure to Align; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A DISCOID ENDOMETRIOSIS, THE DEVICE HAD FIRING ISSUES. THE ANVIL BROKE AND DISENGAGED. THE ANVIL PIVOTED AT THE TIME OF OPENING THE CLAMP BEFORE STAPLING. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20489072 ↗
• MalfunctionDec 19, 2023Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A COMPLEX ENDOMETRIOSIS WITH DISCOID RESECTION, THE ANVIL TILTED BEFORE CLOSING THE SUTURE. A NEW CLAMP WAS USED TO RESOLVE THE ISSUE. THE OPERATION TIME WAS EXTENDED BUT NOT MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360049 ↗
• MalfunctionSep 18, 2023Loss of or Failure to Bond; Material Twisted/Bent; Loss of or Failure to Bond; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOMETRIOSIS DISCOID RESECTION PROCEDURE, DURING THE ANASTOMOSIS SUTURE DISCOID, THE ANVIL WAS DIFFICULT TO LOAD AND THE ANVIL WAS BENT. IT WAS NOTED THAT THE ANVIL TILTED BEFORE THE DIGESTIVE SUTURE DISCOID. IMPOSSIBLE TO REUSE THE FORCEPS FOR SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769673 ↗
• MalfunctionJun 15, 2023Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE FOR ENDOMETRIOSIS, BEFORE BEING USED ON A PATIENT THE ANVIL ROTATED. IT WAS ALSO REPORTED THAT THE ANVIL BENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135805 ↗

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