Multifire Premium 059037Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521080690), received between Jan 8, 2019 and May 25, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN OPEN PROCEDURE, ON SKIN CLOSURE, THE PATIENT HAD AN ALLERGIC REACTION AND WAS COMPLAINING OF ITCHING AND IRRITATION DUE TO THE STAPLE.

  Patient problems: Foreign Body Reaction; Itching Sensation; Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 14497990 ↗
• MalfunctionMar 8, 2022Entrapment of Device; Failure to Form Staple; Detachment of Device or Device Component; Entrapment of Device; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A POSTERIOR LUMBAR THREE TO SACRAL ONE RECONSTRUCTION, WHILE CLOSING THE WOUNDS, THE DEVICE HAD POOR STAPLE FORMATION AND WHEN THE SURGEON FIRED THE STAPLER, IT DID NOT ALLOW HIM TO PULL THE STAPLER AWAY. CARTRIDGE FELL OUT FROM THE HANDLE. THE SURGEON USED A NEW STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693633 ↗
• MalfunctionMar 1, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A C-SECTION PROCEDURE, WHILE PLACING THE DRESSING ON THE PATIENT, THE STAPLES HAD POOR FORMATION AND CAME UNDONE. THE SURGEON RE-STAPLED THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13637412 ↗
• MalfunctionNov 20, 2019Scratched Material

  THIS STAPLER HAS BEEN KNOWN TO LEAVE JAGGED EDGES ON STAPLES, WHICH CAN LEAD TO RIPPING OF GLOVES AND POTENTIALLY A BLOOD BORN EXPOSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9346807 ↗
• InjuryMay 31, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, AT THE END OF CASE WHILE GRAFTING, A POOR STAPLE FORMATION WAS OBSERVED. THE SKIN STAPLER DID NOT FULLY COME TOGETHER. THE SKIN WAS THINK AND THE STAPLES WERE PARTIALLY FORMED. MORE CLIPS AND SUTURES WERE USED. OVERSEWING WAS PERFORMED TO FIX STAPLE LINE.

  Patient problems: No Code Available

  MAUDE report 8658032 ↗
• MalfunctionMay 21, 2019Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION AND INTERNAL FIXATION C6-7 FRACTURE WITH OPTICAL TRACKING, THE TWO SKIN STAPLERS DID NOT FIRE WHEN TRIGGERED, THEN THE MAGAZINE FELL OUT/BECAME DETACHED FROM THE STAPLE GUN. THE DEVICES WERE REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628239 ↗
• MalfunctionJan 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN SQUEEZING THE TRIGGER ON THE HANDLE WHILE CLOSING THE SKIN DURING AN OPEN PROCEDURE, THE CARTRIDGE FLEW ACROSS THE ROOM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8226890 ↗