LIGACLIP EL414Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20705036003868), received between Nov 21, 2017 and Oct 27, 2022 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, CLIP APPLICATOR WAS NOT WORKING PROPERLY. CLIPS ARE NOT FORMED PROPERLY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683716 ↗
• MalfunctionAug 17, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE THE CLIP APPLICATOR DID NOT WORK. CLIPS NOT FORMING PROPERLY .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240585 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP APPLIER WAS NOT CLAMPING THE CLIPS DOWN TIGHT. THE PROCEDURE WAS FINISHED AND THEN HOURS LATER THE PATIENT STARTED BLEEDING FROM THE SITE. UNKNOWN IF PATIENT WILL REQUIRE REPEAT SURGICAL PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14355658 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP APPLIER WAS NOT CLAMPING THE CLIPS DOWN TIGHT. THE PROCEDURE WAS FINISHED AND THEN HOURS LATER THE PATIENT STARTED BLEEDING FROM THE SITE. UNKNOWN IF PATIENT WILL REQUIRE REPEAT SURGICAL PROCEDURE,

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14355533 ↗
• MalfunctionApr 25, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY THE CLIP APPLICATOR (EL414) WAS NOT WORKING PROPERLY. THERE WAS A 20 MINUTE DELAY IN THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197189 ↗
• MalfunctionSep 3, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP DOESN¿T REMAIN FIXED IN DEVICE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422105 ↗
• MalfunctionJun 17, 2021Difficult to Insert; Mechanical Problem; Insufficient Device Problem Information; Difficult to Insert; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN STAFF ATTEMPTED TO USE THE DEVICE, THEY HEARD A POPPING SOUND AND WERE UNABLE TO LOAD A CLIP. THE JAWS APPEARED TO BE FURTHER APART THAN THEY SHOULD BE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022260 ↗
• MalfunctionMay 20, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE LIGACLIP FORCEPS EL414 HAD FAILED. THE ISSUE IS THAT THE MECHANISM OF THE DEVICES IS WORKING TOO QUICKLY DURING THE INITIAL PHASE AND WHILST THE JAWS CLOSE THEY DIDN'T SHUT FULLY. WHEN THE SURGEON TRIES TO COMPLETE THE CYCLE THE JAWS DON'T OPEN AND RETRACT INTO THEIR ORIGINAL POSITION. THIS MEANT THE DEVICE WAS LOCKED AROUND A PIECE OF TISSUE AND HAD TO BE CUT FREE BY THE SURGEON. DURING THE CASE IN QUESTION THE SURGEON WAS ABLE TO RESOLVE THIS AND THE PATIENT CAME TO NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859919 ↗
• MalfunctionApr 30, 2021Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIPS WERE NOT BEING RELEASED PROPERLY FROM THE CLIP APPLICATOR. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757867 ↗
• MalfunctionJul 30, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DID NOT TIGHTEN THE CLIPS. THE PHYSICIAN USED ANOTHER CLIP APPLIER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348365 ↗
• MalfunctionMay 10, 2019Failure to Form Staple; Defective Device

  IT WAS REPORTED THAT DURING A TLH PROCEDURE, PRODUCT WAS NOT WORKING. NOT ABLE TO HOLD CLIP IN JAWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600239 ↗
• MalfunctionFeb 8, 2019Device Slipped

  IT WAS REPORTED THAT DURING A GASTROSTOMY, THE ANGLE OF OPENING AND CLOSING OF THE JAWS IS TOO LARGE. THE CLIP WILL AUTOMATICALLY RELEASE AND SLIP WHEN IT IS CLAMPED. THERE WAS DELAY OF SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8321300 ↗
• MalfunctionJun 19, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOT CLIPPLING WITH THE LT400 CLIP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614943 ↗
• MalfunctionJun 19, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOT CLIPPLING WITH THE LT400 CLIP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614870 ↗
• MalfunctionFeb 23, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CLIPS CHIPPED FROM THE APPLIER AND DON'T CLIP TIGHT. THIS WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293085 ↗
• MalfunctionFeb 7, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, CLIPS NOT CLOSING PROPERLY FROM THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247307 ↗
• MalfunctionDec 15, 2017Failure to Form Staple

  IT WAS REPORTED, BAD CLIP FORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121220 ↗
• MalfunctionNov 21, 2017Failure to Form Staple

  IT WAS REPORTED THAT THE DEVICE DID NOT FORM CLIPS PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7048411 ↗