WECK IPN915191Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 24026704697841), received between Apr 22, 2021 and Mar 4, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE FIRST THREE CLIPS WERE LIGATED TO THE RIGHT BRANCH OF THE RIGHT COLIC ARTERY WITHOUT PROBLEM DURING AN ASCENDING COLECTOMY. WHEN THE USER WAS LIGATING PROBABLY THE FOURTH CLIP, THE APPLIER GOT BROKEN AND SOME FOREIGN MATERIAL WAS SEEN FLYING OFF THROUGH THE MONITOR. THE CLIP WAS IN A CLOSED CONDITION. THE APPLIER WAS TAKEN OUT OF THE ABDOMINAL CAVITY AND CONFIRMED THAT THE JAWS WERE BROKEN. THE INSIDE THE ABDOMINAL CAVITY WAS SEARCHED AND A METAL PIECE, SUPPOSEDLY THE BROKEN PIECE OF THE APPLIER, WAS WITHDRAWN. THE APPLIER WAS REPLACED WITH ANOTHER APPLIER TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513143 ↗
• MalfunctionDec 12, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS AT THE TIP OF THE APPLIER ARE NOT ALIGNED AND COMING OUT OF THE SHAFT." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790878 ↗
• MalfunctionOct 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE TIP OF THE APPLIER GOT TORN OFF WHEN LIGATING A CLIP AND THE BROKEN PIECES FELL IN THE ABDOMINAL CAVITY DURING A RALP. THE USER WITHDREW ALL THE VISIBLE FRAGMENTS FROM THE ABDOMINAL CAVITY, REPLACED THE APPLIER WITH A NEW ONE AND COMPLETED THE SURGERY. NO INJURY TO THE PATIENT WAS REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543918 ↗
• MalfunctionJan 8, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "THE USER ATTEMPTED TO LIGATE A CLIP IN THE PATIENT'S ABDOMINAL CAVITY DURING A SURGERY, BUT THE CLIP WAS NOT LOCKED. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467543 ↗
• MalfunctionDec 11, 2023Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  THE REPORT STATES "IMPOSSIBLE TO REMOVE THE APPLIER WHEN THE CLIP WAS CLOSED ON THE PATIENT'S VESSEL (BECAUSE ONE OF THE 2 JAWS REMAINED ATTACHED TO THE CLIP)". ADDITIONAL INFORMATION STATES "THERE WAS NO CONSEQUENCE FOR THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300129 ↗
• MalfunctionAug 14, 2023Failure to Align; Mechanics Altered; Failure to Align; Mechanics Altered

  IT WAS REPORTED THAT "THE APPLIER JAWS WERE MISALIGNED SO THAT THE CLIP COULD NOT BE LOADED DURING THE PRETEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546209 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKE APART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128071 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKE APART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16126537 ↗
• MalfunctionJan 4, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY, A CLIP GOT BROKEN AT LIGATION, ANOTHER CLIP WAS NOT LOADED TO THE APPLIER PROPERLY, AND THE OTHER CLIP GOT BROKEN AT THE HINGE AT LOADING. THE USER MANAGED TO COMPLETE THE SURGERY WITH THE APPLIER. THE FRAGMENT OF THE CLIP FELL IN THE PATIENT, BUT ALL OF THEM WERE REMOVED AND DISCARDED. NO PATIENT INJURY OCCURRED. THE USER MADE AN INQUIRY TO US THAT THE CLIPS MIGHT HAVE BEEN DEFECTIVE FIRST, BUT WHEN OUR SALES REPRESENTATIVE VISITED THE HOSPITAL AND CHECKED THE APPLIER, HE FOUND THAT THE JAWS WERE SLIGHTLY DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095799 ↗
• MalfunctionDec 20, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST AS THE USER FELT THAT THE CLIP DID NOT EASILY LEAVE THE APPLIER DURING A LAPAROSCOPIC CHOLECYSTECTOMY. NO CLIP FELL IN THE PATIENT. ON FOLLOW-UP, THE SPECIALIST CONFIRMED THAT THE APPLIER COULD NOT BE ASSEMBLED PROPERLY; THE INNER SHAFT GOT DETACHED AFTER ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018035 ↗
• MalfunctionDec 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST AS THE USER FELT THAT THE CLIP DID NOT EASILY LEAVE THE APPLIER DURING A LAPAROSCOPIC CHOLECYSTECTOMY. NO CLIP FELL IN THE PATIENT. ON FOLLOW-UP, THE SPECIALIST CONFIRMED THAT THE APPLIER COULD NOT BE ASSEMBLED PROPERLY; THE INNER SHAFT GOT DETACHED AFTER ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016761 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN A LAPAROSCOPIC CHOLECYSTECTOMY, THE PIN IN THE JAW SHEARED BREAKING INTO PIECES. ALL PIECES WERE REMOVED FROM THE PATIENT AND CONFIRMED USING A-RAY. THERE WAS NO INJURY TO THE PATIENT. THE SURGEON IS AN EXPERIENCED USER OF HEMOLOK. IT WAS CONFIRMED BY THE SURGEON THAT THE DEVICE WAS BEING USED ON THE CYSTIC DUCT AND ANOTHER 5MM HEMOLOK CLIP APPLICATOR WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621012 ↗
• MalfunctionSep 6, 2022Difficult to Open or Close; Difficult to Open or Close

  THE USER COULD LIGATE WITHOUT PROBLEM DURING THE SURGERY. HOWEVER, ACCORDING TO THE USER, WHEN OPENING THE HANDLE, HE/SHE FELT LOOSE/LIGHT, SO THE INNER SHAFT CAME OUT OF THE OUTER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363345 ↗
• MalfunctionDec 9, 2021Material Twisted/Bent; Material Twisted/Bent

  THE INNER SHAFT WAS BENT SO THAT THE APPLIER COULD NOT BE ASSEMBLED SMOOTHLY BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 10 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967332 ↗
• MalfunctionOct 4, 2021Break; Material Disintegration; Break; Material Disintegration

  CUSTOMER REPORTED THAT DURING USE IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR TEP, THE PIN IN THE JAW SHEARED BREAKING INTO 3 PIECES. CLINICAL CONSEQUENCES: ALL 3 PIECES WERE REMOVED FROM THE PATIENT WITH NO INJURY TO PATIENT. THE SURGEON IS A VERY EXPERIENCED USER OF HEMOLOK. THEY CONCLUDED THEY HAD APPLIED TO MUCH FORCE THROUGH THE HANDLE WHEN LIGATING. THE CUSTOMER DID NOT FEEL THIS WAS A PRODUCT COMPLAINT BUT I AN LOGGING AN INTERNAL COMPLAINT FOR COMPLETENESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569578 ↗
• MalfunctionJul 21, 2021Material Twisted/Bent; Material Twisted/Bent

  THE APPLIER JAWS GOT BENT DURING USE. THEREFORE, IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE SURGERY. THE APPLIERS WERE PURCHASED BY THE HOSPITAL IN AUGUST 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202119 ↗
• MalfunctionApr 22, 2021Break; Break

  THE TIP OF THE APPLIER GOT BROKEN IN THE PATIENT WHILE IN USE DURING LAPAROSCOPIC HEPATECTOMY. NO PARTS/FRAGMENTS WERE CONFIRMED BY X-RAY AFTER PROCEDURE. HOWEVER, THE USER WOULD LIKE US TO CHECK IF ANY PARTS ARE MISSING ON THE APPLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706660 ↗