NA ETHMCL20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888551019057), received between Jun 21, 2018 and Dec 17, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2021Failure to Fire; Mechanical Jam; Failure to Fire; Mechanical Jam

  IT WAS REPORTED THAT A (B)(6), MALE, PATIENT UNDERWENT A LAPAROSCOPIC OPEN CHOLECYSTECTOMY PROCEDURE WITH FOUR REPROCESSED CLIP APPLIERS LIGACLIP AND DURING THE PROCEDURE, THE FOUR CLIP APPLIERS FAILED TO FIRE. A FIFTH CLIP WAS USED AND WORKED AS EXPECTED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025833 ↗
• MalfunctionNov 22, 2021Use of Device Problem; Failure to Fire

  PATIENT WITH A HISTORY OF COMORBIDITIES INCLUDING OF HIGH BLOOD PRESSURE, DIVERTICULITIS AND HYPERCHOLESTEROLEMIA, PREVIOUS PROCEDURE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND STONE EXTRACTION FROM THE COMMON BILE DUCT, WAS ADMITTED FOR A LAPAROSCOPY AND OPEN CHOLECYSTECTOMY. DURING THE PROCEDURE, THE FOUR MCL20 REPROCESSED MULTI CLIP APPLIER OPENED AND FAILED TO FIRE. A TOTAL OF FOUR FAILED. A FIFTH CLIP WAS USED AND WORKED AS EXPECTED. NO KNOWN HARM TO PATIENT. PICTURES INCLUDE ALL 4 DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 12851433 ↗
• MalfunctionApr 20, 2020Contamination /Decontamination Problem

  ELDERLY MALE WITH RECENT HISTORY OF PIGMENTED IRREGULARLY SHAPED NODULAR SKIN LESION. UNDERGOING WIDE EXCISION MELANOMA, LEFT SHOULDER WITH SENTINEL NODE BIAXIAL, FULL THICKNESS SKIN GRAFT. THE ETHICON LIGACLIP MCA (REPROCESSED) HAD DEBRIS IN PACKAGING. OBSERVATION WAS MADE PRIOR TO OPENING PACKAGING, NOT USED ON PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9976895 ↗
• InjuryJul 2, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT A RADICAL RETROPUBIC PROSTATECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY PROCEDURE WITH TWO REPROCESSED CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS AND THE DEVICE DID NOT CLOSE PROPERLY, THEREFORE DID NOT CLAMP THE VESSEL AND INCREASED BLEEDING. BOTH DEVICES WERE REPLACED, AND A THIRD DEVICE COMPLETED THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8754331 ↗
• InjuryJul 2, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A RADICAL RETROPUBIC PROSTATECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY PROCEDURE WITH TWO REPROCESSED CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS AND THE DEVICE DID NOT CLOSE PROPERLY, THEREFORE DID NOT CLAMP THE VESSEL AND INCREASED BLEEDING. BOTH DEVICES WERE REPLACED, AND A THIRD DEVICE COMPLETED THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8754330 ↗
• MalfunctionJun 28, 2019Difficult to Open or Close

  MD ATTEMPTED TO USE THE REPROCESSED OPEN ENDOCLIP. THESE INSTRUMENTS ARE NOT ABLE TO CLOSE PROPERLY AND THEREFORE DON'T CLAMP THE VESSEL AND INCREASE BLEEDING. WE USED TWO OF THESE INSTRUMENTS BEFORE WE WERE ABLE TO FIND ONE THAT WORKED. THE THIRD ONE WORKED.

  Patient problems: Blood Loss

  MAUDE report 8744469 ↗
• InjuryJun 21, 2018Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPS AND THE CLIPS DID NOT FIRE CORRECTLY WHICH CAUSED THE VESSEL TO BE SEVERED. DURING THE PROCEDURE, DURING USE OF THE DEVICE THE DAMAGE OF THE VESSEL WAS IDENTIFIED IMMEDIATELY. THE PATIENT¿S VESSEL WAS REPAIRED AND EXTENDED HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT HAS SINCE FULLY RECOVERED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS DUE TO PRODUCT MALFUNCTION.

  Patient problems: Perforation of Vessels

  MAUDE report 7627337 ↗