WECK IPN028126Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 34026704625193), received between Feb 4, 2021 and Feb 23, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT A CLIP WAS FOUND BROKEN WHEN THE USER ATTEMPTED TO LOAD IT DURING A SURGERY. ACCORDING TO THE USER, IT WAS UNKNOWN WHETHER THE CLIP HAD BEEN BROKEN BEFORE LOADING OR IT GOT BROKEN AT LOADING. NO CLIP FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366204 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT A CLIP WAS FOUND BROKEN WHEN THE USER ATTEMPTED TO LOAD IT DURING A SURGERY. THEREFORE, A NEW UNIT WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366193 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO LIGATE A CLIP DURING SURGERY IT GOT BROKEN. IT OCCURRED TO 4 CLIPS IN TOTAL. THEREFORE, A NEW CARTRIDGE WAS OPENED INSTEAD. A BROKEN PIECE OF THE CLIP FELL IN THE PATIENT, BUT IT WAS WITHDRAWN; NOTHING REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343160 ↗
• MalfunctionFeb 18, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CLIP WAS FOUND STUCK INTO THE APPLIER WHEN BEING UPLOADED; CHANGED TO OTHER CLIP TO CONTINUE THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342795 ↗
• MalfunctionFeb 9, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT ON (B)(6) 2021, IN (B)(6), THE INNER PACKAGE WAS FOUND NOT SEALED COMPLETELY, AND THE CUSTOMER HAS CONCERN ON THE STERILITY PRIOR TO THE PATIENT BY THE NURSE HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304923 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE USER LOADED THE CLIP ON THE APPLIER, THE CLIP BROKE (PRIOR TO USE ON THE PATIENT). TO SOLVE WE USED CLIPS FROM A CARTRIDGE FROM THE SAME LOT NUMBER AND 2 OTHER CARTRIDGES FROM A DIFFERENT LOT NUMBER WITH SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304787 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT A CLIP WAS FOUND DETACHED FROM THE CARTRIDGE SLOT AND BROKEN WHEN THE USER ATTEMPTED TO LOAD IT DURING A SURGERY. THEREFORE, A NEW UNIT WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304718 ↗
• InjuryFeb 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  POST-OP BILE LEAK AFTER LAP CHOLE. THE BILE LEAK WAS NOT FROM THE CYSTIC DUCT. IT WAS FROM THE FIRST ERCP. THE FIRST ERPC AND SECOND ERCP BOTH SHOW THE CYSTIC DUCT OCCLUDED. THE CLIPS WERE NOT THE ISSUE. A SURGICAL INTERVENTION WAS PERFORMED TO REPAIR THE BILE LEAK AND HOSPITALIZATION WAS EXTENDED. THE CLIPS, 2 APPLIED, DID NOT COME OFF THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282709 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT 2 CLIPS GOT BROKEN AT THE HOOK WHEN THEY WERE LOADED DURING A SURGERY. THEREFORE, A NEW UNIT WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278887 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT 2 CLIPS GOT BROKEN AT THE HOOK WHEN THEY WERE LOADED DURING A SURGERY. THEREFORE, A NEW UNIT WAS OPENED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278752 ↗