LIGACLIP MCS20Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 10705036002499), received between Aug 29, 2017 and Jul 6, 2026 — classified as 1 death, 7 injuries, 329 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (248 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 337 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Failure to Form Staple; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY THE CLIP APPLIER HAD CLIPS SCISSORING AND NOT FIRING PROPERLY. THE APPLIER WAS THROW AWAY BUT REP WAS GIVEN A OPENED APPLIER WITH THE SAME LOT. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25720801 ↗
• MalfunctionJul 6, 2026Failure to Form Staple; Failure to Fire; Mechanics Altered

  IT WAS REPORTED THAT DURING A PLASTIC SURGERY A CLIP APPLIER DIDN'T WORK. THE DEVICE LOCKED OUT AND GOT STUCK IN THE APPLIER AND ON THE SECOND FIRING IT SCISSORED AND CUT THE VESSEL. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25720792 ↗
• MalfunctionJun 11, 2026Failure to Form Staple

  IT WAS REPORTED, THAT THE MCS20 HAD ¿SCISSORED¿ DURING A BREAST CASE. WAITING ON INFORMATION REGARDING SURGEON AND OTHER DETAILS. NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25476972 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIP APPLIERS NOT WORKING. SPOKE WITH SURGEON AND HE SAID WHILE DEPLOYING THE CLIPS THEY COME OUT TOO FAST OR DON'T STAY AFTER BEING CLIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331083 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIP APPLIERS NOT WORKING. SPOKE WITH SURGEON AND HE SAID WHILE DEPLOYING THE CLIPS THEY COME OUT TOO FAST OR DON'T STAY AFTER BEING CLIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331040 ↗
• MalfunctionMay 26, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280482 ↗
• MalfunctionMay 23, 2026Failure to Form Staple; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE MCS20 DISPOSABLE CLIP APPLIERS, PARTICULARLY IN COMMANDO PROCEDURES WITHIN ENT SURGERY, SPECIALISTS EXPERIENCE RECURRING ISSUES WITH CLIP FORMATION. ON AVERAGE, AT LEAST THREE CLIPS PER DEVICE ARE REPORTED TO BE MALFORMED, RESULTING IN INADEQUATE CLOSURE, CLIP DISLODGEMENT, OR BLEEDING. IN ADDITION, MECHANICAL ISSUES ARE FREQUENTLY OBSERVED, INCLUDING FAILURE TO FIRE OR INCOMPLETE FIRING. THE PROCEDURES WERE DELAYED BY 15 MINUTES AND COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25264579 ↗
• MalfunctionMay 18, 2026Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WERE ISSUES WITH THE SMALL CLIP APPLIER SCISSORING WHILE ATTEMPTING TO PLACE CLIPS. THEY MENTIONED THAT ONE OF THE ATTEMPTS RESULTED IN THE DEVICE CUTTING THE SMALL VESSEL. PLACEMENT OF ADDITIONAL CLIP REQUIRED. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209727 ↗
• MalfunctionMay 15, 2026Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WERE ISSUES WITH THE SMALL CLIP APPLIER MCS20 SCISSORING WHILE ATTEMPTING TO PLACE CLIPS. THEY MENTIONED THAT ONE OF THE ATTEMPTS RESULTED IN THE DEVICE CUTTING THE SMALL VESSEL. PLACEMENT OF ADDITIONAL CLIP REQUIRED. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184367 ↗
• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS DIDN'T CLOSE PROPERLY AT THE TIP. THEY WERE ALWAYS MISALIGNED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119162 ↗
• MalfunctionMay 7, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE SURGEON MENTIONED THAT THESE PARTICULAR CLIP APPLIERS CUT THE VEIN INSTEAD OF CLIPPING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114232 ↗
• MalfunctionMay 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLES CROSSED OVER ONE ANOTHER, WHICH PREVENTED PROPER DEPLOYMENT AND INTERFERED WITH THE SURGEON¿S ABILITY TO USE THE DEVICE AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082647 ↗
• MalfunctionMay 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLES CROSSED OVER ONE ANOTHER, WHICH PREVENTED PROPER DEPLOYMENT AND INTERFERED WITH THE SURGEON¿S ABILITY TO USE THE DEVICE AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082632 ↗
• MalfunctionMay 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLES CROSSED OVER ONE ANOTHER, WHICH PREVENTED PROPER DEPLOYMENT AND INTERFERED WITH THE SURGEON¿S ABILITY TO USE THE DEVICE AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082576 ↗
• MalfunctionMay 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLES CROSSED OVER ONE ANOTHER, WHICH PREVENTED PROPER DEPLOYMENT AND INTERFERED WITH THE SURGEON¿S ABILITY TO USE THE DEVICE AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082338 ↗
• MalfunctionApr 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER CLAMPED THE CLIPS AND CLIP COULD NOT CLOSE. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048646 ↗
• MalfunctionApr 22, 2026Mechanical Jam; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT WHILE PROVIDER WAS USING THE ETHICON ENDO-SURGERY DISPOSABLE CLIP APPLIER, THE CLIP APPLIER WAS NOT LOADING ANY CLIPS WHICH THEN CAUSED THE CLIP APPLIER TO TEAR THROUGH THE VEIN VERSUS CLIP AN APPENDAGE OF THE VEIN. IT SHOT BLANKS SEVERAL TIMES, WHEN IT SHOULD HAVE HAD CLIPS LOADED INTO THE INSTRUMENT. NEW CLIP APPLIER WAS THROWN TO THE STERILE FIELD. PRODUCT GIVEN TO LEADERSHIP WITH PART LABEL. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24958223 ↗
• MalfunctionApr 21, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY PROCEDURE, DEVICE DID NOT DISPERSE CLIPS ADEQUATELY RESULTING IN CLIP NOT BEING APPLIED TO TISSUE. SMALL CLIP APPLIER DISPOSABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945473 ↗
• MalfunctionApr 6, 2026Failure to Form Staple; Failure to Fire; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, FAILURE OF CLIP DEPLOYMENT. SURGEONS EXPERIENCED CRISS-CROSSED CLIPS; CLIPS NOT DEPLOYED OR FAILED TO CLOSE PROPERLY AND CLIPS CUTTING ON THE VESSELS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794229 ↗
• MalfunctionApr 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A NECK LYMPH NODE DISSECTION, CLIPS WERE PLACED ON A BLOOD VESSEL, BUT THEY IMMEDIATELY DISLODGED. A SECOND CLIP APPLIER WAS OPENED, BUT THE CLIPS ALSO DISLODGED. THERE WAS NO BLOOD LOSS. A REUSABLE CLIP APPLIER FROM ANOTHER SUPPLIER WAS THEN OPENED, AFTER WHICH THE CLIPS REMAINED IN PLACE AND THE PROCEDURE COULD BE CONTINUED. THE PROCEDURE WAS DELAYED BY 5 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793751 ↗
• MalfunctionApr 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A NECK LYMPH NODE DISSECTION, CLIPS WERE PLACED ON A BLOOD VESSEL, BUT THEY IMMEDIATELY DISLODGED. A SECOND CLIP APPLIER WAS OPENED, BUT THE CLIPS ALSO DISLODGED. THERE WAS NO BLOOD LOSS. A REUSABLE CLIP APPLIER FROM ANOTHER SUPPLIER WAS THEN OPENED, AFTER WHICH THE CLIPS REMAINED IN PLACE AND THE PROCEDURE COULD BE CONTINUED. THE PROCEDURE WAS DELAYED BY 5 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793733 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPEN-HEART PROCEDURE, THE PATIENT WAS BROUGHT BACK DUE TO POSTOPERATIVE BLEEDING. IT WAS REPORTED THAT THE CLIP PLACED ON THE MAMMARY ARTERY HAD BECOME LOOSE, RESULTING IN THE BLEEDING EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24792914 ↗
• MalfunctionApr 3, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PLASTIC PROCEDURE THERE WERE THREE CLIP APPLIERS WERE USED. ONE CLIP APPLIER DIDN'T FIRE, AND THE OTHER TWO CLIP APPLIERS THE ENDS CAME TOGETHER SO NO CLIP COULD COME OUT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783868 ↗
• MalfunctionApr 3, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PLASTIC PROCEDURE THERE WERE THREE CLIP APPLIERS WERE USED. ONE CLIP APPLIER DIDN'T FIRE, AND THE OTHER TWO CLIP APPLIERS THE ENDS CAME TOGETHER SO NO CLIP COULD COME OUT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783202 ↗
• MalfunctionApr 3, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SURGICAL VASCULAR CLIP SHOULD HAVE BEEN PROPERLY ALIGNED; HOWEVER, IT WAS INCOMPLETELY APPLIED DUE TO MISALIGNMENT OF THE CLIP TIP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781662 ↗