NA ETHMSM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551019095), received between Jun 21, 2018 and Apr 12, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Fire” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO MULTI CLIP APPLIER LIGACLIP SMALL CLIPS AND ONE MULTIPLE CLIP APPLIER LIGACLIP MCA AND ALL OF THE DEVICES HAS SCISSORING CLIPS. THE DEVICES WERE EXCHANGED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS REPORT IS FOR THE MULTIPLE CLIP APPLIER LIGACLIP MCA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510416 ↗
• 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 7627397 ↗