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PENTAX FUR-9RBSRecalls & reported problems

Hoya Corporation · PORTABL URETERORENO SCOPE FUR-9RBS · 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 04961333227839), received between Jun 21, 2022 and Sep 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Optical Distortion1

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.

  • MalfunctionSep 5, 2023Break; Break

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17680766 ↗
  • MalfunctionJun 21, 2022Optical Distortion; Optical Distortion

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14751440 ↗

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.