ILA 3973Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521063181), received between Jun 14, 2018 and Sep 18, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2019Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, LAPAROSCOPIC WEDGE RESECTION, AN UNKNOWN ISSUE OCCURRED WITH THE DEVICE. SEWING WAS DONE TO RESOLVE THE ISSUE ON ORDER TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9085081 ↗
• MalfunctionDec 3, 2018Misfire; Failure to Form Staple; Detachment of Device or Device Component; Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE BEING APPLIED ON ANASTOMOSIS ON AN OPEN JEJUNOSTOMY, THERE WAS A POOR STAPLE FORMATION WHERE STAPLES DID NOT FORM COMPLETE B SHAPE AND NOTICED AN INCOMPLETE STAPLE LINE. IT WAS ALSO NOTED THAT STAPLES FELL INTO LUMEN. THEY PERFORMED COLIC SURGERY AS SURGICAL INTERVENTION AND THE SURGICAL TIME WAS EXTENDED FOR 25 MINUTES. LATER, THEY CONVERTED TO HAND SEW TO COMPLETE THE CASE. THE PATIENT EXPERIENCED COLIC POST-OPERATIVELY AND EVENTUALLY LED TO CARDIAC TROPONIN. THE PATIENT IS DECEASED.

  Patient problems: Cardiac Arrest; Death; Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8126518 ↗
• MalfunctionNov 28, 2018Misfire; Failure to Form Staple; Detachment of Device or Device Component; Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE BEING APPLIED ON ANASTOMOSIS ON AN OPEN JEJUNOSTOMY, THERE WAS A POOR STAPLE FORMATION WHERE STAPLES DID NOT FORM COMPLETE B SHAPE AND NOTICED AN INCOMPLETE STAPLE LINE. IT WAS ALSO NOTED THAT STAPLES FELL INTO LUMEN AND WERE PASSED. THEY HAD TO OVER SEW THE STAPLE LINE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8113833 ↗
• 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 7601466 ↗