WECK IPN028494Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 34026704631798), received between Apr 22, 2022 and Nov 25, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE CHARGER OF THE STAPLER IS BLOCKED. THE ISSUE OCCURRED AT THE START OF THE PROCEDURE; IT WAS NOT PRETESTED. RECURRING PROBLEM. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15865126 ↗
• MalfunctionJul 25, 2022Failure to Form Staple; Failure to Form Staple

  THE SKIN STAPLER FAILS. THE CLIPS SITS TO HIGH ON THE SKIN AND THE STAPLER HAS DIFFICULTY GRASPING THE WOUND EDGES. THE WOUND IS NOT SUFFICIENT CLOSED AFTER USE. DOCTOR TENDS TO REMOVE THE CLIPS AND SUTURE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093203 ↗
• MalfunctionJun 13, 2022Failure to Form Staple; Failure to Form Staple

  THE ORHOPIDS FIND THAT THE STAPLES DO NOT CLOSE NICELY AND SO THE WOUND SUBSEQUENTLY DOES NOT CLOSE FROM SKIN STAPLER 528236. CLINICAL CONSEQUENCES: INFECTIONS HAVE OCCURRED IN THE PATIENTS.

  Patient problems: Impaired Healing

  MAUDE report 14674812 ↗
• MalfunctionJun 9, 2022Failure to Form Staple; Failure to Form Staple

  THE ORHOPIDS FIND THAT THE STAPLES DO NOT CLOSE NICELY AND SO THE WOUND SUBSEQUENTLY DOES NOT CLOSE FROM SKIN STAPLER 528236. CLINICAL CONSEQUENCES: INFECTIONS HAVE OCCURRED IN THE PATIENTS. PATIENT CONDITION OR TREATMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14644700 ↗
• MalfunctionApr 22, 2022Failure to Form Staple; Failure to Form Staple

  USE OF THE STAPLER TO FIX THE SKIN AT THE END OF THE OPERATION, BUT THE STAPLES DO NOT HOLD WELL TO THE SKIN AND COME OFF AT THE SLIGHTEST CONTACT WITH THE SCAR. CLINICAL CONSEQUENCES: UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14187961 ↗
• MalfunctionApr 22, 2022Failure to Form Staple; Failure to Form Staple

  USE OF THE STAPLER TO FIX THE SKIN AT THE END OF THE OPERATION BUT THE STAPLES DO NOT HOLD WELL TO THE SKIN AND COME OFF AT THE SLIGHTEST CONTACT WITH THE SCAR. CLINICAL CONSEQUENCES: UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14187213 ↗