LIGACLIP EL314Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 20705036003851), received between Nov 22, 2017 and Apr 7, 2026 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (18 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, SURGEON WAS USING OUR LIGACLIP (ENDOSCOPIC APPLIER) IN SURGERY & WHILE APPLYING THE CLIP, THE CLIP IS NOT HOLDING BACK AND SLIPS OUT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807812 ↗
• MalfunctionDec 17, 2025Failure to Form Staple; Mechanical Jam; Failure to Form Staple; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BOTH THE ROTATING KNOB IS NOT WORKING, DEVICE NOT FUNCTIONING CORRECTLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828382 ↗
• MalfunctionDec 17, 2025Failure to Form Staple; Mechanical Jam; Failure to Form Staple; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BOTH THE ROTATING KNOB IS NOT WORKING, DEVICE NOT FUNCTIONING CORRECTLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827771 ↗
• MalfunctionApr 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, HANDPIECE IS TWISTED AND NOT ALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939948 ↗
• MalfunctionApr 22, 2025Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE NOT CLOSING AND THE VESSEL IS NOT FULLY CLIPPED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882435 ↗
• MalfunctionApr 22, 2025Failure to Form Staple; Appropriate Device Problem Term/Code Not Available; Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE NOT CLOSING AND THE VESSEL IS NOT FULLY CLIPPED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882433 ↗
• MalfunctionApr 1, 2025Failure to Form Staple; Insufficient Device Problem Information; Failure to Form Staple; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, POSSIBLE QUALITY DEVIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740751 ↗
• MalfunctionDec 12, 2024Difficult to Insert; Difficult to Open or Close; Difficult to Insert; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPPER WAS STUCK AND DID NOT TAKE THE CLIPS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919238 ↗
• MalfunctionSep 18, 2024Unintended Ejection; Mechanical Problem; Failure to Form Staple; Unintended Ejection; Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, JAWS ARE NOT ALIGNED PROPERLY, SO THE CLIPS ARE NOT APPLIED PROPERLY ON THE TISSUE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250123 ↗
• MalfunctionSep 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM CLIPS BREAK DURING POSITIONING IN THE SURGICAL AREA. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207123 ↗
• MalfunctionApr 24, 2024Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIPS ARE NOT FORMED PROPERLY AND THE JAWS ARE NOT PROXIMATE. CLIPS ALSO SLIPPED OUT FROM THE JAWS. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175179 ↗
• MalfunctionNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, THE CLIPS WERE NOT WORKING PROPERLY. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. UNKNOWN OF ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233423 ↗
• MalfunctionFeb 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY, WHEN OPERATING THE HANDLEBAR SO THAT THE CLIP IS CLOSED. THE TIP DOES NOT SEAL COMPLETELY, MAKING IT DIFFICULT TO POSITION THE TIP. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323700 ↗
• InjuryAug 26, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST OP TO A LAPAROSCOPIC CHOLECYSTECTOMY THE PATIENT WAS FOUND TO HAVE 3,000 ML OF BLOOD IN THE ABDOMEN. THE PATIENT WAS REOPERATED ON AND IT WAS DISCOVERED THE CLIPS DID NOT CLOSE IN THE MIDDLE. THIS WAS CORRECTED AND FOUR UNITS OF BLOOD WERE GIVEN AND THE PATIENT IS IMPROVING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15300742 ↗
• InjuryAug 24, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST OP TO A LAPAROSCOPIC CHOLECYSTECTOMY THE PATIENT WAS FOUND TO HAVE 3,000 ML OF BLOOD IN THE ABDOMEN. THE PATIENT WAS REOPERATED ON AND IT WAS DISCOVERED THE CLIPS DID NOT CLOSE IN THE MIDDLE. THIS WAS CORRECTED AND FOUR UNITS OF BLOOD WERE GIVEN AND THE PATIENT IS IMPROVING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15286971 ↗
• MalfunctionAug 22, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP DID NOT CLOSE SECURELY AND IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264793 ↗
• MalfunctionJan 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE WASN'T WORKING PROPERLY AND CLIPS WERE GETTING LOOSENED OR THEY FELL OFF WHEN APPLIED ("TRIED CHECKING IT INSIDE OT"). THE CLIPS WERE NOT HOLDING TISSUE/VESSEL. THERE WAS NO PATIENT CONSEQUENCE AS THEY HAD ANOTHER APPLIER OF SOME OTHER COMPANY THROUGH WHICH THEY COMPLETED THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13162404 ↗
• MalfunctionSep 3, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE LAP CLIP APPLIER JAW WAS OPENED AND WAS NOT WORKING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422487 ↗
• MalfunctionJan 15, 2021Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SURGEON MENTIONED CLIP DOESN'T CLIP PROPERLY AND CLIPS FALLS OUT. CLIPS WOULD NOT HOLD IN JAWS AND CLIPS WOULD NOT HOLD ON TISSUE. CLIPS WERE NOT MALFORMED. THERE WAS NO DELAY TO PROCEDURE, ANOTHER DEVICE WAS USED, AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11180019 ↗
• MalfunctionJan 15, 2021Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SURGEON MENTIONED CLIP DOESN'T CLIP PROPERLY AND CLIPS FALLS OUT. CLIPS WOULD NOT HOLD IN JAWS AND CLIPS WOULD NOT HOLD ON TISSUE. CLIPS WERE NOT MALFORMED. THERE WAS NO DELAY TO PROCEDURE, ANOTHER DEVICE WAS USED, AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179888 ↗
• MalfunctionNov 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A CLIPPER FAILURE. IT WAS IMPOSSIBLE TO SECURE THE CLIP BY THE DEVICE. THERE WAS NOT DELAY TO PROCEDURE, PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10839408 ↗
• InjuryNov 14, 2019Device Slipped

  IT WAS REPORTED THAT POST-OP, AFTER A CHOLECYSTECTOMY PROCEDURE, USING THIS TYPE OF FORCEPS, EL314, AN INCIDENT INVOLVING A PATIENT OCCURRED IN 2017 LEADING TO A LIFE-THREATENING COMPLICATION, RE-OPERATION, AND PROLONGED CONVALESCENCE. IN PATIENT, THE CLIPS FELL OUT RESULTING IN BILE DRAINING INTO THE ABDOMINAL CAVITY, PERITONITIS, AND RE-SURGERY DURING WHICH THE DETACHED CLIPS WERE OBSERVED."

  Patient problems: Failure to Anastomose; No Code Available; Not Applicable; Peritonitis

  MAUDE report 9322977 ↗
• InjuryNov 12, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE PROCEDURE WAS COMPLETED FINE. THE CLIP WAS DETACHED FROM THE "BILE DUCTULE" AFTER THE CHOLECYSTECTOMY OPERATION. THIS HAPPENED AFTER SOME DAYS FROM THE OPERATION. IT WAS ALSO REPORTED THAT THIS LEAD TO A LIFE-THREATENING COMPLICATION, RE-OPERATION, AND PROLONGED CONVALESCENCE. THE CLIPS FELL OUT RESULTING IN BILE DRAINING INTO THE ABDOMINAL CAVITY, PERITONITIS, AND RE-SURGERY DURING WHICH THE DETACHED CLIPS WERE OBSERVED. THEY DON'T KNOW EXACTLY WHICH CLIP APPLIER IT WAS AS THEY HAVE TEN OF THE SAME EL314 CLIP APPLIERS IN USE AT THIS FACILITY. THEY ALSO REPORTED "THIS REFERS TO MULTIPURPOSE FORCEPS THAT ARE USED TO CLOSE THE COMMON BILE DUCT DURING GALLBLADDER SURGERY AND TO SECURE METALLIC CLOSURE CLIPS IN PLACE. THE FORCEPS REQUIRE A TWO-STEP PRESSING PROCESS TO FIRST CREATE A CONVEX CLOSURE OF A CLIP AND DURING THE SECOND STEP, TO SECURE THE CLOSURE OF THE CLIP. THE FINAL SQUEEZE REQUIRES A SUBSTANTIAL AMOUNT OF FORCE. NOT ALL USERS ARE AWARE OF THIS TWO-STEP PROCESS."

  Patient problems: Failure to Anastomose; No Code Available; Not Applicable; Peritonitis

  MAUDE report 9310931 ↗
• MalfunctionJun 13, 2019Corroded; Failure to Align; Failure to Form Staple

  IT WAS REPORTED THAT THE CLIP APPLIER PRESENTED WITH OXIDIZED RINGS AND BAD CLIP FORMATION DUE TO THE MISALIGNED JAWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696679 ↗
• MalfunctionApr 19, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE IS CLOSING STAPLES INCORRECTLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532218 ↗