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Gyrus ACMI BPS-YRecalls & reported problems

Gyrus ACMI, LLC · Adjustable Biopsy Port Seal Y-Adapter (5/PK) · 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 00821925031494), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

  • Contamination /Decontamination Problem1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionFeb 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

    ADDITIONAL EVENT INFORMATION WAS RECEIVED NOTING THAT THE HAIR WAS INSIDE THE SEALED PACKAGING. ACCORDING TO THE REPORTER, THERE WAS NO DAMAGE TO THE PACKAGE OF THE DEVICE. THERE WERE NO OTHER ISSUES KNOWN WITH ANY OTHER PACKAGING OR DEVICES IN THE SAME LOT NUMBER. THE PROBLEM WAS NOTED DURING PROCEDURE PREPARATION.

    Patient problems: No Patient Involvement

    MAUDE report 11317586 ↗

Other Ureteroscope and accessories, flexible/rigid devices

All Ureteroscope and accessories, flexible/rigid devices →

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