ILA 3975Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521064614), received between Jun 14, 2018 and Jan 20, 2019 — classified as 1 injury, 1 malfunction.

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

• InjuryJan 20, 2019Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A DURING FUNCTIONAL END-TO-END ANASTOMOSIS IN TRANSVERSE COLECTOMY. THE DEFECT OCCURRED WHEN CLOSING THE COMMON HOLE AFTER SIDE-BY-SIDE ANASTOMOSIS. AT THE FIRST FIRING, WHILE GRASPING THE TISSUE AND PROCEEDING THE FIRING, IT BECAME HARD FROM THE HALFWAY AND THE KNIFE BAR BECAME BENT ALTHOUGH THE FIRING ADVANCED TO THE END. WHEN OBSERVING THE TISSUE AFTER RELEASING THE DEVICE, IT WAS FOUND THAT THE STAPLES WERE APPLIED, BUT THE CUTTING WAS ONLY HALF WAY DONE. THE TISSUE THAT WAS NOT SEPARATED COMPLETELY WAS CUT WITH AN ELECTROSURGICAL KNIFE AND REINFORCED WITH THE NEEDLE AND THREAD, AND THE OPERATION WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 8263234 ↗
• MalfunctionJun 14, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SUB TOTAL GASTRECTOMY PROCEDURE, AT THE FIRST FIRING, THE RELOAD WAS CONNECTED TO THE STAPLER, THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER THE PLASTIC KNOB DID NOT ADVANCE. A NEW RELOAD WAS USED AND CONNECTED THE SAME STAPLER, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601742 ↗