EEA 020250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521047471), received between Oct 30, 2018 and Jul 1, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN SIGMOID RESECTION PROCEDURE. THIS WAS AN EMERGENCY PROCEDURE BEING PERFORMED TO REPAIR A TEAR IN THE SIGMOID COLON THAT OCCURRED WHILE THE PATIENT WAS UNDERGOING A COLONOSCOPY. IT WAS REPORTED THAT THE STAPLER SIZER ALSO TORE THE TISSUE AND HAD TO BE REPAIRED USING SUTURE. THEN THE STAPLER WAS INSERTED TRANS-ANALLY INTO THE DISTAL BOWEL AND FIRED TO ANASTOMOSE THE PROXIMAL AND DISTAL BOWEL. UPON INSPECTION, THE ANASTOMOSIS WAS REPORTED TO HAVE NOT BEEN FULLY DEVELOPED. THE SURGEON THEN USED A SMALLER STAPLER TO SUCCESSFULLY PERFORM THE ANASTOMOSIS. FINALLY, A DIVERTING ILEOSTOMY WAS PERFORMED. UNKNOWN AT THIS TIME IF THE ILEOSTOMY WAS TEMPORARY OR PERMANENT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES DUE TO THE PRODUCT PROBLEM. THE WAS PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Code Available; Tissue Damage

  MAUDE report 8747959 ↗
• InjuryOct 30, 2018Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE ON COLON DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE SIZE MAY HAVE BEEN TOO LARGE AND TORE THE TISSUE. WHEN IT WAS EXTRACTED FROM THE PATIENT, THE STAPLE LINE SEEMED INTACT. THEY TRIED TO OVERSEW BUT THE TISSUE WAS BAD. EVENTUALLY, THEY REMOVED THE ANASTOMOSIS AND REDID WITH THE SAME DEVICE WHICH WAS SMALLER IN DIAMETER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8019546 ↗