WECK IPN915182Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 24026704695915), received between Mar 29, 2021 and Aug 14, 2023 — classified as 9 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Break” (121 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 25 most recent of 162 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "ACCORDING TO THE USER, THERE WAS A POSSIBILITY THAT A CLIP MIGHT HAVE FALLEN INTO THE ABDOMINAL CAVITY DURING SURGERY AND IT MIGHT HAVE REMAINED IN THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED." ADDITIONAL INFORMATION STATES THAT "THE CLIP FELL OUT OF THE APPLIER WHEN THE APPLIER WAS TAKEN OUT OF THE ABDOMINAL CAVITY." THERE WERE NOT ANY ATTEMPTS MADE TO RETRIEVE THE CLIP FROM THE PATIENT'S CAVITY AS "THE USER SEARCHED IN THE OPERATIVE FIELD, BUT COULD NOT FIND THE CLIP". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540601 ↗
• MalfunctionJul 24, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. 1 PC INVOLVED. THEN USE ANOTHER CLIP (THE SAME BATCH). MORE INFORMATION IS CURRENTLY UNKNOWN, PENDING SALES FOLLOW-UP." AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383814 ↗
• MalfunctionJul 11, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300440 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PHYSICIAN ATTEMPTED TO LIGATE THE CYSTIC DUCT, HOWEVER THE CLIP DIDN'T CLOSE/LOCK. THE PHYSICIAN ATTEMPTED AGAIN WITH ANOTHER CLIP FROM THE SAME CARTRIDGE AND THIS CLIP BROKE IN TWO PIECES AND FELL INTO THE PATIENT. ONE PIECE OF THE CLIP WAS FOUND AND REMOVED, HOWEVER AFTER SEARCHING THE PATIENT'S CAVITY THE OTHER PIECE OF THE CLIP WAS NOT FOUND. "THE SEGMENT MIGHT HAVE STILL BEEN IN THE PATIENT, BUT THE PHYSICIAN DECIDED TO FINISHED THE PROCEDURE." NO PATIENT HARM OR INJURY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070508 ↗
• MalfunctionJun 6, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PHYSICIAN ATTEMPTED TO LIGATE THE CYSTIC DUCT, HOWEVER THE CLIP DIDN'T CLOSE/LOCK. THE PHYSICIAN ATTEMPTED AGAIN WITH ANOTHER CLIP FROM THE SAME CARTRIDGE AND THIS CLIP BROKE IN TWO PIECES AND FELL INTO THE PATIENT. ONE PIECE OF THE CLIP WAS FOUND AND REMOVED, HOWEVER AFTER SEARCHING THE PATIENT'S CAVITY THE OTHER PIECE OF THE CLIP WAS NOT FOUND. "THE SEGMENT MIGHT HAVE STILL BEEN IN THE PATIENT, BUT THE PHYSICIAN DECIDED TO FINISHED THE PROCEDURE." NO PATIENT HARM OR INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070331 ↗
• MalfunctionMay 2, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A CLIP COULD NOT BE LOADED INTO THE APPLIER PROPERLY DURING USE. THE USER OPENED ANOTHER CARTRIDGE AND COULD LOAD THE CLIPS WITHOUT PROBLEM TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT. NO PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856134 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CLIP "BROKE." THE ISSUE WAS RESOLVED BY USING ANOTHER CLIP. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16775738 ↗
• MalfunctionApr 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT "THE USER FOUND SOMETHING LIKE A FRAGMENT OF THE CARTRIDGE IN THE PATIENT BODY DURING A SURGERY. HE/SHE WITHDREW IT AND OPENED A NEW CARTRIDGE TO COMPLETE THE PROCEDURE. NOTHING REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED." ADDITIONAL INFORMATION STATES THAT "THE FRAGMENT WAS RETRIEVED OUT OF THE PATIENT BY FORCEPS. THE PATIENT CONDITION POST INTERVENTION WAS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712831 ↗
• MalfunctionApr 5, 2023Break; Break

  REPORTED ISSUE: A CLIP GOT BROKEN WHEN IT WAS LOADED TO THE APPLIER DURING THE PRETEST AT THE CENTRAL MATERIAL ROOM. THE APPLIER USED WITH HAD ALREADY BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683055 ↗
• MalfunctionMar 28, 2023Difficult to Open or Close; Difficult to Open or Close

  REPORTED ISSUE: THE CLIPS DO NOT CLOSE PROPERLY, THEY BREAK AND ARE DISPERSED IN THE OPERATING FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627032 ↗
• MalfunctionMar 27, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  REPORTED ISSUE: THE CLIPS DO NOT CLOSE PROPERLY, THEY BREAK AND ARE DISPERSED IN THE OPERATING FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624645 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED ISSUE: FOUR CLIPS OUT OF SIX FELL FROM THE APPLIER AT LOADING DURING A SURGERY. THE USER OPENED A NEW CARTRIDGE, BY WHICH COMPLETED THE SURGERY WITHOUT PROBLEM. NO CLIP FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616206 ↗
• MalfunctionMar 18, 2023Break; Break

  REPORTED ISSUE: TWO CARTRIDGES OF HEMOLOCK CLIPS FROM THE SAME LOT#73H2000219 CONTAINED ONLY BROKEN CLIPS. THEY WERE NOT POSSIBLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569648 ↗
• MalfunctionMar 17, 2023Break; Break

  REPORTED ISSUE: A CLIP GOT BROKEN WHEN IT WAS LOADED TO THE APPLIER DURING THE PRETEST AT THE CENTRAL MATERIAL ROOM. THE APPLIER USED WITH HAD ALREADY BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567517 ↗
• MalfunctionMar 16, 2023Break; Break

  REPORTED ISSUE: TWO CARTRIDGES OF HEMOLOCK CLIPS FROM THE SAME LOT#73H2000219 CONTAINED ONLY BROKEN CLIPS. A THIRD CARTRIDGE WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561021 ↗
• MalfunctionMar 15, 2023Break; Break

  REPORTED ISSUE: ON (B)(6) 2023, THE CLIP WAS FOUND BROKEN DURING USAGE ON THE PATIENT. THERE WAS ONE PIECE INVOLVED. ANOTHER CLIP WAS USED AND THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549862 ↗
• MalfunctionMar 15, 2023Difficult to Open or Close; Difficult to Open or Close

  REPORTED ISSUE: ON (B)(6)2022, THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ONE PIECE WAS INVOLVED. ANOTHER CLIP WAS USED AND THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548249 ↗
• MalfunctionMar 6, 2023Break; Break

  REPORTED ISSUE: THE CLIP WAS FOUND BROKEN WHEN LOADED ON THE APPLIER. NO BROKEN PARTS FELL IN THE PATIENT. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491568 ↗
• MalfunctionMar 1, 2023Difficult to Open or Close; Difficult to Open or Close

  REPORTED ISSUE: THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ANOTHER CLIP WAS USED. THERE WAS NO REPORTED INJURY. THE SAME APPLIER INVOLVED SUCCESSFULLY CLOSED OTHER CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462354 ↗
• MalfunctionFeb 24, 2023Break; Break

  REPORTED EVENT: CLIPS BROKE DURING PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 16437944 ↗
• MalfunctionFeb 24, 2023Break; Break

  REPORTED ISSUE: CLIPS BROKE DURING THE PROCEDURE. NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16437455 ↗
• MalfunctionFeb 23, 2023Break; Break

  REPORTED ISSUE: WHEN A NURSE LOADED A CLIP TO THE APPLIER DURING A SURGERY, IT GOT BROKEN. THEREFORE, A NEW CARTRIDGE WAS OPENED INSTEAD TO COMPLETE THE SURGERY. NO CLIP FELL/REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430703 ↗
• MalfunctionFeb 15, 2023Separation Failure; Separation Failure

  REPORTED EVENT: DURING A ROBOTIC SURGERY THE DOCTOR HAS ENCOUNTERED THE DIFFICULTY RELEASING THE CLIP IN SITU BECAUSE IT PRESENTS AN EXCRESCENCE THAT BLOCKS THE RELEASE FROM THE INSTRUMENT, BOTH ROBOTIC AND LAPROSCOPIC. HE HAD TO HELP WITH AN ADDITIONAL ROBOTIC ARM TO FREE THE STUCK CLIPS. IT WAS REPORTED THAT SUBSEQUENT CLIP APPLICATION WAS SUCCESSFUL AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380324 ↗
• MalfunctionFeb 8, 2023Break; Break

  REPORTED EVENT: THE CLIP WAS FOUND BROKEN WHEN LOADED ON APPLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328715 ↗
• InjuryJan 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORTED EVENT: THE SURGEON PERFORMED LAPAROSCOPIC CHOLECYSTECTOMY ON A PATIENT. AFTER SURGERY, THE SURGEON NOTICED BILE SPILLAGE IN THE PATIENT'S BODY, SO THE FOLLOW-UP SURGERY WAS PERFORMED. DURING THE FOLLOW-UP SURGERY, THE SURGEON FOUND THAT ONE OF TWO CLIPS HAD MIGRATED FROM CYSTIC DUCT AND ANOTHER CLIP MIGRATED WHEN THE SURGEON TOUCHED IT WITH AN INSTRUMENT. TWO CLIPS FELL IN THE PATIENT, BUT BOTH WERE REMOVED FROM THE PATIENT'S BODY AND THE FOLLOW-UP SURGERY WAS SUCCESSFULLY FINISHED. IT WAS ALSO REPORTED THAT ACCORDING TO THE SURGEON NECROSIS OF THE CYSTIC DUCT, OR DAMAGE TO THE CYSTIC DUCT DURING THE FIRST SURGERY, MAY HAVE CAUSED BILE SPILLAGE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: Biliary Leak

  MAUDE report 16229910 ↗