WECK IPN008820 (REF 528236)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704600779), received between Aug 12, 2021 and Aug 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT "STAPLES APPEAR TO BE BENT AND DO NOT CLOSE THE SKIN STAPLE SEAM WELL". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654851 ↗
• MalfunctionAug 24, 2023Use of Device Problem; Failure to Form Staple; Use of Device Problem; Failure to Form Staple

  IT WAS REPORTED THAT "WHEN THEY STAPLED THE SKIN THEY NOTICED THAT THE STAPLERS ONLY CLOSED HALF WAY AND FELL OFF". THE USER THEN ATTEMPTED TO FIRE THE STAPLER AWAY FROM THE PATIENT AND FIELD AS A TEST AND NOTICED THAT "THE STAPLES DID NOT COME TOGETHER BUT WERE HALF OPEN". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617851 ↗
• MalfunctionAug 12, 2021Failure to Form Staple; Failure to Form Staple

  CUSTOMER COMPLAINTS THAT STAPLER DOES NOT WORK PROPERLY - THE STAPLES PENETRATE ONLY ONE SIDE OF THE SKIN. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THE STAPLES DO NOT HOLD TO THE SKIN AND A LOOSE SUTURE IS SEEN WITH SCAR DISUNION. THE RISKS FOR THE PATIENT WERE AN IMMEDIATE OR LATER DISUNION LEADING TO A HEALING AND AESTHETIC DEFECT. LOCAL CARE WITH DIRECTED HEALING HAD TO BE IMPLEMENTED AT HOME AND THERE MAY BE A NEED FOR REMOTE REVISION SURGERY FOR COSMETIC DAMAGE. THE INCIDENT WAS RESOLVED BY USING A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313102 ↗