Multifire Premium 059035Recalls & reported problems
Covidien LP · Pistol Grip Skin Stapler · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521080676), received between Apr 4, 2019 and Dec 14, 2022 — classified as 4 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
Device problems
- Detachment of Device or Device Component3
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN RIGHT GASTROCNEMIUS RESECTION AND ANKLE ARTHROSCOPY, AT CLOSURE, THE CLIP CARTRIDGE DISENGAGED WITH FIRST FIRING AND FELL ON THE FLOOR. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15982814 ↗MalfunctionJan 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC TRAUMA PROCEDURE, WHILE CLOSING THE SKIN, THE RELOAD DETACHED FROM HANDLE. SURGEON USED ANOTHER SKIN STAPLER TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9647908 ↗MalfunctionJun 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN CRANIOTOMY PROCEDURE, WHILE ATTACHING THE DRAPES TO THE PATIENT¿S SCALP, THE HANDLE OF THE 1ST DEVICE BROKE. IT WAS NOTED THAT WHEN CLOSING THE SCALP AT THE END PF THE PROCEDURE, THE CARTRIDGE OF THE 2ND DEVICE INADVERTENTLY DISENGAGED FROM HANDLE. MULTIPLE STAPLERS WERE USED IN PLACE OF TWO STAPLERS TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8737140 ↗MalfunctionApr 4, 2019Mechanical Jam; Mechanical Jam
ACCORDING TO THE REPORTER, THE STAPLER JAMMED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8484935 ↗
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- Proximate PXW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)37 reports
- Proximate PRW35Ethicon Endo-Surgery, LLC · STAPLE, REMOVABLE (SKIN)20 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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