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
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- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.