URETERO-RENO FIBERSCOPE OLYMPUS URF-P7R (REF N5781944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170435102), received between Dec 1, 2023 and Nov 21, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K181451); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THE URETERO-RENO FIBERSCOPE HAD DAMAGE TO THE MAIN CHANNEL. THE ISSUE OCCURRED DURING SETUP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746414 ↗
• MalfunctionSep 18, 2024Particulates; Particulates

  IT WAS REPORTED, THE URETERO-RENO FIBERSCOPE HAD CRYSTALS ON THE END OF THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251667 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE FIBERSCOPE'S DISTAL CAP EXPLODED, CAUSING PARTS TO FALL OFF FROM THE DISTAL END. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183568 ↗
• MalfunctionAug 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETERO-RENO VIDEOSCOPE EXHIBITED WEAR OF ANGLE WIRE AND BENDING SECTION CANNOT BE CONTROLLED AT ALL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962781 ↗
• MalfunctionMay 9, 2024Device Reprocessing Problem; Poor Quality Image; Device Reprocessing Problem; Poor Quality Image

  IT WAS REPORTED THAT DURING THE REPROCESSING OF THE FIBERSCOPE, IT WAS PROCESSED WITHOUT THE GAS CAP ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277325 ↗
• MalfunctionFeb 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE EXHIBITED BENDING SECTION COVER GLUE HAD A CHIP/MISSING ON ONE SIDE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807859 ↗
• MalfunctionJan 25, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THE FIBERSCOPE HAD AN IMAGE PROBLEM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585120 ↗
• MalfunctionJan 4, 2024Leak/Splash; Leak/Splash

  A CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE URETERO-RENO FIBERSCOPE FAILED A LEAK TEST AND BLACK DOTS WERE INSIDE THE DISTAL TIP LENS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: THERE WAS A HOLE/CUT IN THE BENDING SECTION COVER THAT WAS LEAKING. 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 18447071 ↗
• MalfunctionDec 11, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE URETERO-RENO FIBERSCOPE HAD BLACK SPOTS IN THE SCOPE DUE TO BROKEN FIBER. THE ISSUE WAS FOUND DURING INSPECTION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: EYEPIECE HAS FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM. 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 18301151 ↗
• MalfunctionDec 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE URETERO-RENO FIBERSCOPE HAD FOREIGN MATERIAL FALLING FROM THE CHANNEL AND THERE WAS LUBRICATION LEAKING OUT. THE ISSUE WAS OBSERVED DURING RECEIPT INSPECTION AND NOTED AS AN OUT-OF-BOX FAILURE FOR USE ON AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281523 ↗
• MalfunctionDec 1, 2023Mechanical Problem; Optical Problem; Mechanical Problem; Optical Problem

  AN OLYMPUS FIELD SERVICE ENGINEER REPORTED ON BEHALF OF THE CUSTOMER THAT THEY HAVE FOUND MULTIPLE BLACK DOTS FROM THE URETERO-RENO FIBERSCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: ANGULATION BECOMES LOCKED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 18247959 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181451. One submission often covers many models, so check the product and lot details in each record.

• Z-0348-2024 · Sep 25, 2023 · Open, Classified
  Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.