GIA Premium 030735LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521031630), received between Jun 8, 2018 and Sep 23, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOTOMY RESECTION OF LUNG TISSUE, THE LUNG TISSUE WAS PLACED WITHIN BRANCHES THEN THE BRANCHES JOINED TOGETHER. THE SURGEON WAITED FOR 15 SECONDS AND THEN THE CUTTING PROCESS WAS INITIATED BUT THE STAPLE FUNCTION DID NOT WORK PROPERLY SO NO COMPLETE ROW OF STAPLES HAD BEEN FORMED. USED ANOTHER DEVICE FROM THE COMPETITOR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10574275 ↗
• InjuryMay 20, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN GASTRECTOMY, WHEN FIRING STOMACH, POOR STAPLE FORMATION WAS OBSERVED. THE STAPLE LINE HAD TO BE OVERSEWN TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 10076615 ↗
• MalfunctionJul 22, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE TWO RELOADS FIRED PARTIALLY. THE OPERATOR PULLS OUT THE KNOB TWICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8810333 ↗
• MalfunctionApr 1, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, WHILE DIVIDING THE COLON, THE SURGEON COULD NOT FIRE THE DEVICE. THE BLACK PUSHER THUMB COULD NOT BE MOVED AT ALL. AFTER INSPECTION OF THE RELOAD, THEY NOTICED THAT THERE WERE NO STAPLES IN ROWS. THEY USED A NEW RELOAD WITH THE SAME HANDLE, AND EVERYTHING GONE WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471687 ↗
• InjuryJun 8, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LEFT-SIDED HEMICOLECTOMY PROCEDURE, WHILE DOING THE SIDE-TO-SIDE ANASTOMOSIS, THE KNIFE DID NOT CUT THE TISSUE BETWEEN THE ROWS OF STAPLES ON ONE SIDE ONLY. IT CLOSED ONE SIDE WITH DENSELY 4 ROWS OF STAPLES AND THE OTHER LEFT OPEN. TIME OF SURGERY EXTENDED OVER 30 MINUTES WITH LOSS OF ADDITIONAL TISSUE DUE TO DEFECT AND MANUAL ANASTOMOSIS WAS DONE. THE EVENT ALSO LEAD TO EXTENDED HOSPITALIZATION OF 8 DAYS.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 7582591 ↗