OES URETERO-RENO FIBERSCOPE OLYMPUS URF TYPE P5 (UDI 04953170316593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170316593), received between Mar 4, 2021 and Nov 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023Mechanical Problem; Poor Quality Image; Material Deformation; Mechanical Problem; Poor Quality Image; Material Deformation

  THE CUSTOMER REPORTED OES URETERO-RENO FIBERSCOPE WAS HAVING IMAGE ISSUE AND MULTIPLE BLACK DOTS ON THE VISION, BROKEN FIBER IMAGE PROBLEM, AND ANGULATION WAS NOT GOOD AND COULD NOT ANGULATE SUFFICIENTLY. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: FORCEPS CHANNEL PORT WAS DEFORMED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130020 ↗
• MalfunctionMay 16, 2022Material Deformation; Material Deformation

  A USER FACILITY REPORTED TO OLYMPUS, THE OES URETERO-RENO FIBERSCOPE EXHIBITED MULTIPLE BLACK DOTS IN THE IMAGE, AND ANGULATION ISSUE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE SCOPE BENDING SECTION REPEATEDLY ANGULATED IN THE DOWNWARD DIRECTION DUE TO DEFORMATION OF THE BENDING SECTION. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413631 ↗
• MalfunctionMar 4, 2021Break; Break

  OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND THAT THE BENDING SECTION KEPT ANGULATED, DUE TO THE BROKEN ANGLE WIRE CAUSING THE END TO COME APART. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409981 ↗