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USA Elite EIWERecalls & reported problems

Gyrus ACMI, LLC · USA Elite System Iglesias Working Element · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925001916), received between Jul 20, 2021 and Jul 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

Device problems

  • Crack1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 20, 2021Crack; Leak/Splash; Crack; Leak/Splash

    IT WAS REPORTED THAT DURING REPROCESSING, CRACK IN THE BLACK HANDLE OF THE DEVICE WAS OBSERVED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED. DEVICE RETURN TESTING FOUND THE DEVICE FAILED LEAKAGE TEST DUE TO LEAKED BETWEEN HANDLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12200195 ↗

Other CYSTOURETHROSCOPE devices

All CYSTOURETHROSCOPE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.