NA ETHMCM30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551019071), received between May 28, 2019 and Nov 22, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY WITH TWO REPROCESSED MULTIPLE CLIP APPLIER LIGACLIPS AND WHEN CLIP APPLIER FIRED IT DID NOT CLOSE ON TISSUE. A NEW NON-REPROCESSED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED BECAUSE OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852307 ↗
• MalfunctionNov 22, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY WITH TWO REPROCESSED MULTIPLE CLIP APPLIER LIGACLIPS AND WHEN CLIP APPLIER FIRED IT DID NOT CLOSE ON TISSUE. A NEW NON-REPROCESSED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED BECAUSE OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852304 ↗
• InjuryJun 21, 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 LYMPH NODE DISSECTION PROCEDURE WITH A REPROCESSED MULTIPLE CLIP APPLIER LIGACLIP AND THE CLIPS BECAME SCISSORED WHICH CAUSED A BLEEDING ISSUE. THE PHYSICIAN TRIED TO CONTROL BLEEDING WITH THE CLIP APPLIER AND THE REPROCESSED CLIP APPLIER WAS NOT FUNCTIONING CORRECTLY. FROM THE START OF THE CASE, THE CLIPS WOULD NOT CLAMP THE VESSELS NO MATTER HOW HARD THE SURGEON WOULD SQUEEZE. ABOUT EVERY THIRD CLIP, THEY WOULD CRISSCROSS OR SCISSOR AT THE TIP. NO MATTER WHAT THE SURGEONS WOULD DO THEY WOULD NOT STAY ON THE VESSELS. THERE WAS SIGNIFICANT BLEEDING BUT WITH SOME ADDITIONAL FIGURE-OF-EIGHT SUTURES HEMOSTASIS WAS IMPROVED. NO ADDITIONAL, MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. A BRAND-NEW CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8723058 ↗
• MalfunctionMay 28, 2019Defective Device

  THE REPROCESSED LIGACLIP FAILED. THE PHYSICIAN TRIED TO CONTROL BLEEDING WITH CLIP APPLIER. THE REPROCESSED CLIP APPLIER WAS NOT FUNCTIONING CORRECTLY AND A BRAND NEW CLIP APPLIER WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8645209 ↗