WECK IPN914814Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704672896), received between Aug 16, 2021 and Nov 22, 2021 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Failure to Form Staple; Failure to Form Staple

  THIS IS THE FIRST TIME WE HAVE HAD THIS PROBLEM. THE FAILURE WAS NOTICED DURING THE INTERVENTION DURING ITS USE. THE SAMPLE IS WITHIN OUR PREMISES BUT IT IS CONTAMINATED. THERE WERE NO CONSEQUENCES FOR THE PATIENT OR THE STAFF BUT IT WAS NECESSARY TO USE A NEW STAPLER SO OPEN A NEW CUSTOM PACK KIT. ADDITIONAL INFORMATION: THE STAPLES ARE TWISTED AND DO NOT FUNCTION CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856202 ↗
• MalfunctionAug 16, 2021Failure to Form Staple; Failure to Form Staple

  THE STAPLES DO NOT HOLD TO THE SKIN AND A LOOSE SUTURE IS SEEN WITH SCAR DISUNION. UNFORTUNATELY, I DO NO HAVE ANY PHOTOS OR SAMPLE. THE DEFECT WAS NOTICED IMMEDIATELY UPON APPLICATION. THE STAPLES DO NOT HOLD AND THE SKIN BECOMES INVAGINATED. THE RISKS FOR THE PATIENT WERE AN IMMEDIATE OR LATER DISUNION LEADING TO A HEALING AND AESTHETIC DEFECT. LOCAL CARE WAS PROVIDED WITH DIRECTED HEALING HAD TO BE IMPLEMENTED AT HOME AND THERE MAY BE A NEED FOR REMOTE REVISION SURGERY FOR COSMETIC DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325670 ↗