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SlimLine MRO-715ARecalls & reported problems

Gyrus ACMI, LLC · SlimLine Self-Dilating Autoclavable Operating Self-Rigid Ureteroscope · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925010970), received between Feb 13, 2023 and Feb 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1
  • Obstruction of Flow1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionFeb 16, 2023Material Deformation; Material Deformation

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING A WORKING CHANNEL ISSUE WAS DISCOVERED, THE SCOPE LIGHT CORD DOES NOT FIT UNDER THE CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16390693 ↗
  • MalfunctionFeb 13, 2023Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING REPROCESSING A BLOCKAGE WAS DISCOVERED IN THE WORKING CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE SUBJECT DEVICE WAS SENT BACK TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING THE FOLLOWING WAS FOUND: UNABLE TO PASS GUIDE WIRE INTO THE FORCEPS CHANNEL. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (UNABLE TO PASS GUIDE WIRE INTO THE FORCEPS CHANNEL).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16368991 ↗

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.