endomina platformRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05425029282018), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN INTERVENTION USING THE ENDOMINA(R) SYSTEM ON (B)(6), 2023, AN ARTERIAL BLEEDING OCCURRED. INTRA-PROCEDURAL HEMOSTASIS WAS SUCCESSFULLY PERFORMED, AND THE PROCEDURE WAS APPROPRIATELY ABORTED. THE DEVICE WAS THROWN AWAY BY THE MEDICAL STAFF IN CHARGE OF THE PROCEDURE AND COULD NOT BE RETRIEVED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITHOUT PROBLEM, AS INITIALLY PLANNED. THE VENDOR'S REPRESENTATIVE ONLY HAD CONFIRMATION OF THE PATIENT STATE OF HEALTH AND DAY OF DISCHARGE THROUGH A PHONE CALL TWO DAYS LATER. SINCE THE INCIDENT CONTACT WAS ESTABLISHED WITH THE SITE AND THE PHYSICIAN AT LEAST ONCE A WEEK. NO OTHER CONCERNS WERE RAISED. ON (B)(6), 2023, COMPANY RECEIVED A MEDWATCH FROM MAYO CLINIC REFERENCE (B)(4). CONTEXT: THE ENDOMINA CASE WAS THE FIRST ONE IN THIS HOSPITAL, THEREFORE, A PHYSICIAN EXPERT IN THE TECHNIQUE AND A VENDOR FIELD SPECIALIST CAME FOR PROCTORING. IT WAS IDENTIFIED THAT THE BLEEDING WAS RELATED TO THE USE OF THE DEVICES AND HAD BEEN CAUSED BY A USER ERROR. ROOT CAUSE ANALYSIS: THE DEVICE RESPONSIBLE FOR THE BLEEDING WAS THE ENDOMINA(R) PLATFORM/ AFTER UNBENDING THE ARM (BENDABLE COIL) OF THE PLATFORM, SOME TISSUE WAS CAUGHT INTO THE SYSTEM WITHOUT BEI

  Patient problems: Gastrointestinal Hemorrhage; Perforation of Vessels

  MAUDE report 17340670 ↗