URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3R (REF N5782122)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170435133), received between Dec 21, 2023 and Apr 14, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL STUCK INSIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876531 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERORENO VIDEOSCOPE EXHIBITED CHIPPED ADHESIVE BENDING SECTION COVER GLUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539110 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THE VIDEOSCOPE UNDERWENT A SCOPE INSPECTION AND FAILED A LEAK TEST. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394834 ↗
• MalfunctionSep 10, 2024Break; Failure to Clean Adequately; Break; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED A BROKEN INSERTION TUBE AND A CLEAR FOREIGN SUBSTANCE WAS FOUND IN THE FORCEPS PASSAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181619 ↗
• MalfunctionJul 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS OBSERVED DURING THE DEVICE MAINTENANCE THAT THE BENDING TUBE OF THE URETERO-RENO VIDEOSCOPE WAS DAMAGED DUE TO METAL PARTS STICKING OUT FROM THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731416 ↗
• InjuryJan 4, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, AT THE END OF THE URETEROSCOPY PROCEDURE, PIECES OF THE OUTER LAYER (BENDING SECTION NEAR THE DISTAL TIP) ON THE URETERO-RENO VIDEOSCOPE WERE FOUND TO BE BROKEN OFF IN THE PATIENT'S BLADDER. THE PIECES WERE RETRIEVED WITH AN ALLIGATOR GRASPER. THERE WAS NO PROCEDURAL DELAY AND NO ADDITIONAL IMAGING WAS REQUIRED AS A RESULT OF THE ISSUE. THE DEFECT IN THE SCOPE MATCHED THE RETRIEVED PIECES. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ANOMALIES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446608 ↗
• InjuryJan 4, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, AT THE END OF THE URETEROSCOPY PROCEDURE, PIECES OF THE OUTER LAYER (BENDING SECTION NEAR THE DISTAL TIP) ON THE URETERO-RENO VIDEOSCOPE WERE FOUND TO BE BROKEN OFF IN THE PATIENT'S BLADDER. THE PIECES WERE RETRIEVED WITH AN ALLIGATOR GRASPER. THERE WAS NO PROCEDURAL DELAY AND NO ADDITIONAL IMAGING WAS REQUIRED AS A RESULT OF THE ISSUE. THE DEFECT IN THE SCOPE MATCHED THE RETRIEVED PIECES. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ANOMALIES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446596 ↗
• MalfunctionDec 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE HAD DEFECTS FROM BENDING RUBBER. THE ISSUE WAS DISCOVERED DURING THE INSPECTION OF THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE IMAGE GUIDE TUBE COAT WAS FOUND PEELING. 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 18411790 ↗
• MalfunctionDec 21, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE URETERO-RENO VIDEOSCOPE CANNOT ANGULATE SUFFICIENTLY. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED AND EVALUATED; THE DISTAL TIP DOES NOT FLEX ALL THE WAY. 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 18372664 ↗

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.