WECK IPN915197Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 24026704696837), received between Apr 19, 2021 and Jul 13, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SCREW OF THE HANDLE WAS FOUND LOOSE WHEN CHECKING IT AT THE HOSPITAL SUPPLY ROOM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321358 ↗
• MalfunctionNov 10, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE JAWS OF THE APPLIER WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15773684 ↗
• MalfunctionSep 6, 2022Failure to Align; Failure to Align

  THE JAWS OF THE APPLIER WERE FOUND MISALIGNED UPON OPENING THE KIT. THE USER TESTED THE APPLIER, BUT IT WAS DIFFICULT TO LOAD A CLIP AND THE CLIP DID NOT EASILY LEAVE THE APPLIER. THEREFORE, A NEW UNIT WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362879 ↗
• MalfunctionJul 26, 2022Failure to Align; Failure to Align

  THE JAWS OF THE APPLIER WERE MISALIGNED DURING USE. THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST, WHO CONFIRMED IT COULD NOT LOAD A CLIP NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103069 ↗
• MalfunctionDec 21, 2021Failure to Align; Failure to Align

  APPLIER MISALIGNED. PRODUCT WILL BE RETURNED FOR REPAIR SO THERE IS NO RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053011 ↗
• MalfunctionDec 6, 2021Failure to Align; Failure to Align

  APPLIER MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933032 ↗
• MalfunctionNov 2, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE CLIPS GOT BROKEN DURING A SURGERY. IT WAS UNKNOWN WHETHER THE ISSUE OCCURRED AT LOADING OR AT LIGATION. THEREFORE, THE APPLIER WAS REPLACED WITH ANOTHER ONE. NO CLIP FELL/REMAINED IN THE PATIENT. THE SALES REPRESENTATIVE CHECKED THE APPLIER AND CONFIRMED THAT THE OPENING OF THE JAWS WAS SLIGHTLY NARROW. THE APPLIER WAS PURCHASED BY THE HOSPITAL ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737838 ↗
• MalfunctionApr 20, 2021Break; Break

  THE HANDLE OF THE APPLIER GOT DETACHED DURING A PRETEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693622 ↗
• MalfunctionApr 19, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE USER FOUND MISALIGNMENT OF THE JAWS BEFORE USE. THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST. HAVING CHECKED THE APPLIER, HE FOUND THAT IT DID NOT OPEN AND CLOSE SMOOTHLY AND THE ROTATION KNOB DID NOT ROTATE PROPERLY, AND CONCLUDED IT WAS UNREPAIRABLE. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 1 YEAR. A NEW APPLIER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686062 ↗