WECK IPN028282Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 34026704623649), received between Sep 8, 2023 and May 15, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED " THE PRODUCT WAS NOT PREFORMING AS DESIRED". ADDITIONAL INFORMATION STATES " THE DEVICE WAS MISALIGNED, AND HE JAWS WERE NOT WORKING". NO PATIENT INVOLVEMENT REPORTED. THIS ISSUE HAPPENED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320168 ↗
• MalfunctionMay 9, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED " THAT THE JAWS OF THE APPLIER DID NOT OPEN/CLOSE EVEN THOUGH GRASPING THE HANDLE DURING THE TEST BEFORE USE. THEREFORE, ANOTHER APPLIER WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279725 ↗
• MalfunctionApr 30, 2024Failure to Align; Failure to Align

  IT WAS REPORTED "BEFORE USING, DOCTOR CHECK THE APPLIER AND FOUND THE JAW ARE NOT EVEN. " THIS WAS FOUND PRIOR TO USE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216427 ↗
• MalfunctionMar 29, 2024Failure to Align; Failure to Align

  IT WAS REPORTED "THE JAWS WERE FOUND MISALIGNED WHEN CHECKING THE APPLIER AT THE HOSPITAL SUPPLY ROOM." NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005869 ↗
• MalfunctionJan 19, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE ROTATION KNOB OF THE APPLIER DID NOT TURN SMOOTHLY SO THAT THE JAWS SOMETIMES KEPT CLOSED DURING A SURGERY. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED. OUR SALES REP. CHECKED THE APPLIER AND FOUND THAT THE JAWS WERE SLIGHTLY MISALIGNED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544610 ↗
• MalfunctionNov 13, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE APPLIER JAWS WERE FOUND MISALIGNED WHEN IT WAS CHECKED IN THE CENTRAL MATERIAL ROOM". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119206 ↗
• MalfunctionSep 8, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE APPLIER JAWS WERE MISALIGNED. AS A RESULT, A NEW APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY, NO CLIPS/PARTS FELL INTO PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714344 ↗