Multifire Endo GIA 030807LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523003772), received between Jun 7, 2017 and Jun 19, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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 19, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN ENDOSCOPIC PHARYNGEAL POUCH STAPLING PROCEDURE, WHEN THE SURGEON TRIED TO FIRE THE DEVICE, IT CUTS THE POUCH BUT NONE OF THE STAPLES WERE DEPLOYED. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AND THERE WAS TISSUE DAMAGE AS A RESULT OF THE DEVICE ISSUE. THE SURGEON TRIED TO FIRE GUN RELOAD (NOT ON THE PATIENT) STAPLES DEPLOYED. THE PATIENT HAD TO UNDERGO AN EMERGENCY OPERATION A WEEK LATER, TO REPAIR THE IATROGENIC ESOPHAGEAL PERFORATION OF THE PATIENT WELL AS THE ASSOCIATED INFECTION, AND THE PATIENT HOSPITALIZATION WAS EXTENDED. THE PATIENT IS STILL CURRENTLY IN THE HOSPITAL, KEPT NBM WITH A NASOGASTRIC FEEDING TUBE, LONG TERM ANTIBIOTIC AND A CORRUGATED DRAIN IN THE NECK TO REMOVE ANY ON-GOING SALIVA & INFECTIVE MATERIAL IN THE NECK/SUPERIOR MEDIASTINUM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10174043 ↗
• MalfunctionMar 21, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) WEDGE RESECTION, THE SECOND UNIT WAS USED AND THE TISSUE WAS CLAMPED BUT NOT COMPLETELY SEVERED BY THE SCALPEL. IT WAS REPORTED THAT THE SCALPEL WAS BENT. ANOTHER STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441916 ↗
• MalfunctionAug 17, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER: DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE WAS STAPLED THE LINE INCOMPLETE. TO FINISH THE PROCEDURE, THE SURGEON HAND SEWN THE OPENING WHERE THE APPENDIX WAS TAKEN OFF. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6801496 ↗
• InjuryJun 7, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE STAPLER ONLY RELEASED STAPLES ON ONE SIDE SO INTESTINE WAS OPEN AND THEY NEEDED TO STAPLE ONE MORE TIME. IN ORDER TO COMPLETE THE CASE, THEY TOOK A NEW RELOAD AND STAPLED ONE MORE TIME. IT WAS NOTED THERE WAS UNANTICIPATED TISSUE LOSS MORE THAN AN ORDINARY SURGERY AND TISSUE DAMAGE AS A RESULT OF THE PROBLEM. THERE WAS NO BLOOD LOSS OF 500CC OR MORE AND THE SURGICAL TIME WAS NOT EXTENDED BY 30 MIN OR MORE. THERE WERE NO TEMPORARY OR PERMANENT COMPLICATIONS. THE PATIENT WAS FINE POST-OP.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6618457 ↗