DURAKNOT SW100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036002888), received between Feb 23, 2018 and Sep 18, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIATAL HERNIA REPAIR THE DEVICE FAILED. THEY COULDN'T GET IT TO WORK AND THE TIP OF THE SUTURE ASSIST WAS DETACHED. DOCTOR IMMEDIATELY SAW AND REMOVED ALL THE PIECES FROM THE SURGICAL AREA AND THEY CHECKED FOR COMPLETENESS OF THE INSTRUMENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082993 ↗
• MalfunctionAug 12, 2019Component Missing

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC J-TUBE PLACEMENT, THE DOCTOR WAS USING THE ENDOSUTURE WITH RELOADS, AND AFTER USING ONE OF THE RELOADS, THE DOCTOR SPOTTED A METAL PIECE RESTING ON SOME TISSUE. THE PIECE WAS REMOVED, INSPECTED AND FOUND TO BE MISSING FROM ONE OF THE RELOADS. UPON CLOSER INSPECTION, A TINY PIECE OF BLUE PLASTIC WAS ALSO SEEN. THESE PIECES WERE ALL SEQUESTERED AND PUT IN A CONTAINER. LATER IN THE CASE, THE DEVICE, ITSELF, CUT OFF TWO NEEDLES FROM THE RELOADS, ERRONEOUSLY. THERE WERE TWO POSSIBLE LOT NUMBERS THIS RELOAD WAS FROM. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884713 ↗
• MalfunctionFeb 23, 2018Device Operates Differently Than Expected

  AFTER MULTIPLE DURAKNOTS WERE FIRED, THE EQUIPMENT BEGAN MALFUNCTIONING. THE ITEM WAS REMOVED FROM THE STERILE FIELD, AND A REPLACEMENT WAS OPENED TO THE STERILE FIELD, WHICH WORKED WITH NO ISSUES. IT IS UNKNOWN WHETHER THE REPLACEMENT SYSTEM WAS FROM THE SAME LOT OR A DIFFERENT LOT. THE OR TEAM HAS BEEN ASKED TO CAPTURE THIS INFORMATION FOR FUTURE EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7291661 ↗