WECK IPN010797Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 14026704553126), received between Jun 12, 2018 and Apr 6, 2026 — classified as 121 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (34 reports).

1 other recall cover devices cleared under the same FDA submission (K152081); they may or may not involve this specific model.

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 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT "THE FIRST CLIP WAS LOADED IN A HALF-CLOSED CONDITION DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE SECOND CLIP AND AFTER WERE LOADED PROPERLY, SO THE AUTO ENDO WAS USED AS IT WAS TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793585 ↗
• MalfunctionMar 24, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT "THE FIRST CLIP WAS NOT PROPERLY POSITIONED WHEN THE DEVICE WAS INITIALLY LOADED, AND THE PRODUCT WAS REPLACED FOR CONTINUED USE". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681691 ↗
• MalfunctionMar 24, 2026Failure to Fire

  IT WAS REPORTED THAT "CLIPS WERE NOT FIRING. NO FURTHER INFORMATION COULD BE CONFIRMED WITH THE CUSTOMER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681609 ↗
• MalfunctionMar 24, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT "THE FIRST CLIP WAS NOT PROPERLY POSITIONED WHEN THE DEVICE WAS INITIALLY LOADED, AND THE PRODUCT WAS REPLACED FOR CONTINUED USE". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681383 ↗
• MalfunctionFeb 18, 2026Difficult to Open or Close

  IT WAS REPORTED THAT "LL THE CLIPS CLEARLY DID NOT OPEN ENOUGH WHEN LOADED DURING A ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY. THEREFORE, HE/SHE STOPPED USING THE AUTO ENDO AND USED HEMOLOK L CLIPS TO COMPLETE THE PROCEDURE. (THE APPLIER USED WITH WAS UNKNOWN.) NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376655 ↗
• MalfunctionFeb 17, 2026Failure to Form Staple

  IT WAS REPORTED THAT "THE THIRD AND THE SIXTH CLIPS WERE NOT LOADED PROPERLY. THE USER TESTED THE AUTO ENDO ONCE OUTSIDE THE PATIENT BODY, HOWEVER, THE 9TH CLIPS AND AFTER WERE ALSO NOT LOADED PROPERLY AND COULD NOT USE, THEREFORE, HE/SHE STOPPED USING THE AUTO ENDO AND USED HEMOLOK L CLIPS TO COMPLETE THE PROCEDURE. (THE APPLIER USED WITH WAS UNKNOWN.) NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369913 ↗
• MalfunctionDec 29, 2025Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT "THE CLIP FAILED TO FULLY OPEN DURING THE LOADING PROCESS. THE PATIENT'S CONDITION IS FINE AND NO MEDICAL INTERVENTION REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907240 ↗
• MalfunctionDec 23, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT "CLIPS WERE NOT FIRING. NO FURTHER INFORMATION COULD BE CONFIRMED WITH THE CUSTOMER."

  Patient problems: Insufficient Information

  MAUDE report 23877783 ↗
• MalfunctionDec 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT "WAS ABLE TO LOAD CLIP INTO JAWS, UNABLE TO CLIP AROUND VESSEL, APPLIER WOULD NOT WORK. SAME LOT NUMBER USED MULTIPLE TIMES TODAY WITHOUT INCIDENT. MANUAL HOL USED INSTEAD." NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831385 ↗
• MalfunctionDec 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "AFTER THE LIGATION CLIP WAS CLOSED, THE CLIP AND THE JAWS OF THE LIGATION FORCEPS COULD NOT BE EASILY REMOVED FROM THE VESSEL. THE PHYSICIAN SUBSEQUENTLY USED SURGICAL INSTRUMENTS TO TRY TO OPEN THE JAWS, ALLOWING THE LIGATION FORCEPS TO BE DETACHED FROM THE VESSEL." NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822466 ↗
• MalfunctionDec 5, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT "THE CLIP WAS RELEASED IN A CLOSED POSITION. THE PATIENT'S CONDITION IS FINE AND NO MEDICAL INTERVENTION REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730006 ↗
• MalfunctionDec 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "A MALFUNTION OCCURRED DURING RELOADING AFTER PRELOADING." NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723122 ↗
• MalfunctionDec 4, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "THE CLIP WAS LOADED IN A CLOSED CONDITION DURING A LAPAROSCOPIC SIGMOIDECTOMY. THE USER TRIED TO LOAD THE CLIPS SEVERAL TIMES, BUT THE SAME ISSUE OCCURRED. THEREFORE, A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723071 ↗
• MalfunctionDec 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT "DURING A PROCEDURE 4 CLIPS DID NOT LOAD PROPERLY, THE FIRST TWO CLIPS DID NOT LOAD PROPERLY WHEN INSERTED IN THE PATIENT, THE DOCTOR RETRACTED THE APPLIER AND GOT 4 CLIPS TO FIRE PROPERLY ON THE PATIENT, THEN WHEN WE WERE EXAMINING THE USED APPLIER AFTER THE CASE, WE HAD TWO MORE CLIPS NOT LOAD PROPERLY". NO PATIENT HARM OR INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722884 ↗
• MalfunctionNov 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT "THE CLIPS WERE LOADED WITHOUT PROBLEM UNTIL THE FIFTH ONE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. HOWEVER, THE SIXTH CLIP AND AFTER WERE LOADED IN A CLOSED CONDITION. THEREFORE, A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650045 ↗
• MalfunctionNov 4, 2025Difficult 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 REPORTED. A NEW AUTO ENDO WAS USED TO PROCEED WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471844 ↗
• MalfunctionOct 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, "DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE DEVICE WAS USED WITHOUT PROBLEM AT FIRST. HOWEVER, THE CLIP COULD NOT BE LOADED PROPERLY IN THE MIDDLE OF THE SURGERY. (ACCORDING TO THE USER, THE SOUND OF THE GEARS THAT MOVE THE CLIPS INSIDE THE AUTO ENDO5 DISAPPEARED.) THEREFORE, THE USER REPLACED THE AUTO ENDO5 WITH HOL ML 5MM ENDO APPLIER AND HEMOLOK ML CLIP TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415435 ↗
• MalfunctionOct 27, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "THE FIRST CLIP CAME OUT IN A CLOSED CONDITION DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY. THE SECOND CLIP AND AFTER WERE LOADED PROPERLY, BUT THE USER REPLACED THE AUTO ENDO TO A NEW ONE TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392999 ↗
• MalfunctionOct 15, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT "CLIP WAS FOUND JAMMING DURING USE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292945 ↗
• MalfunctionOct 8, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "THE FIRST CLIP WAS LOADED WITHOUT PROBLEM DURING A LAPAROSCOPIC ILEOCECAL RESECTION. HOWEVER, WHEN THE USER PULLED THE TRIGGER TO LOAD THE SECOND CLIP, IT WAS NOT LOADED. HE/SHE TOOK THE AUTO ENDO OUT FROM THE PATIENT BODY AND PULLED THE TRIGGER SEVERAL TIMES, BUT NO CLIP COULD BE LOADED. THEREFORE, A NEW UNIT WAS OPENED, BY WHICH THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251317 ↗
• MalfunctionOct 8, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "A CLIP COULD NOT BE FIRED DUE TO JAMMING DURING LOADING THE APPLIER." NO PATIENT INJURY OR CONSEQUENCE REPORTED, NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23250721 ↗
• MalfunctionOct 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT "CLIPS WERE NOT FIRING DURING LOADING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23192335 ↗
• MalfunctionSep 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "THE CLIP GOT STUCK IN THE APPLIER AND DID NOT COME OUT OF THE SHAFT (NOT LOADED) DURING USE. IT OCCURRED 3 TIMES (3 CLIPS JAMMED), BUT THE OTHER CLIPS WERE LOADED PROPERLY, SO THE AUTO ENDO WAS USED AS IT WAS TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23149100 ↗
• MalfunctionSep 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "APPLIER WOULD NOT LOAD ANY CLIPS, LIKE IT WAS JAMMED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23148893 ↗
• MalfunctionSep 25, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT "THE AE05ML PRODUCT WAS USED DURING A LUNG LOBE RESECTION PROCEDURE. DUE TO THE FACT THAT ONLY ONE CLIP CAME OUT WHILE THE REST WERE STUCK AND COULDN'T BE REMOVED, THIS INCIDENT DID NOT CAUSE ANY INJURIES TO PERSONNEL". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23148642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152081. One submission often covers many models, so check the product and lot details in each record.

• Z-0083-2018 · Oct 5, 2017 · Terminated
  WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO