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SlimLine MRO-742ARecalls & reported problems

Gyrus ACMI, LLC · SlimLine Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope · 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 00821925006676), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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

  • Mechanical Problem1

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.

  • MalfunctionFeb 20, 2023Mechanical Problem; Mechanical Problem

    A USER FACILITY RETURNED THE OLYMPUS ASSET, SLIMLINE URETEROSCOPE, TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, A WORKING CHANNEL FAILURE WAS OBSERVED. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16404052 ↗

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.