GIA Premium 030424LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523007091), received between Mar 25, 2016 and Jun 12, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 18, 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.

• InjuryJun 12, 2020Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, WHILE PERFORMING TRUNCATION ON THE PYLORUS OF THE STOMACH DURING AN OPEN HEMICOLECTOMY PROCEDURE, AFTER FIRING, THE DISTAL PORTION OF THE BOWEL REMAINED OPEN AND THE STAPLES WERE FIRED ONLY ON THE PROXIMAL PART OF THE STAPLE LINE. FROM THE STOMACH SIDE ALL OF THE STAPLES WERE FIRED. THE OTHER SIDE, THE DOUDENUM REMAINED OPEN ON THE WHOLE LINE. THERE WERE NO STAPLES FIRED AT ALL. THE BOWEL NEEDED TO BE SEWN MANUALLY BY THE SURGEONS TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR 10 MORE MINUTES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Tissue Damage

  MAUDE report 10148136 ↗
• MalfunctionFeb 19, 2018Component Missing; Mechanics Altered; Component Missing; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLES DID NOT DEPLOY FOR THE RELOAD WAS EMPTY, IT WAS WITHOUT STAPLES. THE SURGEON USED ANOTHER RELOAD FOR THE END OF THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280732 ↗
• MalfunctionAug 23, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN HEMICOLECTOMY PROCEDURE. THE STAPLING DEVICE WAS BEING USED TO DIVIDE THE COLON. THERE WAS POOR STAPLE FORMATION. THERE WAS MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION.EXTRA SUTURES WERE PUT ON THE ANASTOMOSIS. THERE WAS NO UNANTICIPATED TISSUE LOSS OR DAMAGE DUE TO THE PRODUCT PROBLEM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Code Available

  MAUDE report 6813418 ↗
• InjuryMar 25, 2016Component Missing; Component Missing

  ACCORDING TO THE REPORTER: THE MAGAZINE MADE A CUT, BUT DID NOT DEPLOY ANY STAPLES. THE OPERATOR NOTICED AFTERWARDS THAT THERE ARE NO STAPLES INSIDE THE MAGAZINE. THE "PUSHER," THE YELLOW BAR THAT RUNS UNDER THE STAPLES INSIDE THE RELOAD TO PUSH THEM OUT FOR DEPLOYMENT, ALSO APPEARED TO BE MISSING. A NEW MAGAZINE WAS USED. IT WAS REPORTED THAT REINFORCEMENT MATERIAL WAS NOT EMPLOYED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: Injury

  MAUDE report 5527187 ↗