AEON AESR60BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851574008707), received between Nov 13, 2020 and Oct 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Form Staple” (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.

• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AEON ENDOSTAPLER 5.0MM/60MM BLACK RELOAD WAS USED IN A REDO SLEEVE GASTRECTOMY PROCEDURE BY DR. (B)(6) ON (B)(6) 2022. ON THE FIRST FIRE, THE HANDLE WOULD NOT WORK. THE HANDLE WAS REPLACED. ON THE LAST FIRE, ALL OF THE STAPLES DID NOT DEPLOY, AND THERE WAS CONSIDERABLE BLEEDING. THE ENTIRE STAPLE LINE WAS VERY BLOODY, AND THE SURGEON HAD TO SUTURE THE ENTIRE STAPLE LINE. THE SURGERY WAS DELAYED BY MORE THAN 30 MINUTES.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 15663451 ↗
• MalfunctionNov 13, 2020Failure to Form Staple

  THE PHYSICIAN REPORTED THAT DURING THE USE OF THE AEON ENDOSCOPIC STAPLER RELOAD, STAPLES WERE PRESENT IN THE IMPLANTED STAPLE LINE, BUT MULTIPLE STAPLES WERE MISSING. THE PRECISE NUMBER OF MISSING STAPLES WAS NOT REPORTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A LEXINGTON MEDICAL REPRESENTATIVE WAS NOT PRESENT DURING THE CASE. THERE WAS NO PATIENT IMPACT REPORTED. SURGERY WAS NOT DELAYED BY MORE THAN 30 MINUTES. THE PROCEDURE WAS NOT CONVERTED TO OPEN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840597 ↗