Uretero1 URORD101Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00724995209179), received between Mar 15, 2024 and Jan 15, 2026 — classified as 9 malfunctions.

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

• MalfunctionJan 15, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THE IMAGE TO THEIR URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE FROZE DURING A PATIENT PROCEDURE CREATING A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086685 ↗
• MalfunctionJan 5, 2026Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE WAS NOT WORKING AND COULD NOT BE USED DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SCOPE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969702 ↗
• MalfunctionJan 5, 2026Difficult to Advance

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE DISTAL END OF THEIR URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE BECAME OBSTRUCTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SCOPE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968918 ↗
• MalfunctionAug 15, 2025Poor Quality Image; Poor Quality Image

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT "DOCTOR WAS USING THE URETERO1FLEXIBLE URETEROSCOPE AND HAD BEEN WORKED FINE. BUT SUDDENLY, THE IMAGE WAS LOST AND THE SCREEN SAID, "SCOPE NOT DETECTED." WE CHANGED TO ANOTHER MONITOR, BUT SAME MESSAGE SHOWED. THE PROCEDURE WAS ALMOST FINISHED AT THAT TIME; HE DIDN'T NEED ANOTHER URETERO1. THE PATIENT HAS NO INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819610 ↗
• MalfunctionAug 7, 2025Poor Quality Image; Poor Quality Image

  THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) THAT, "URETERO1, DISPOSABLE FLEXIBLE URETEROSCOPE IMAGE GETS CUT OFF, INTERMITTENTLY LOST AND KEEPS CUTTING OUT OR FLICKERING. OR TEAM FOUND A CRACK AT THE BASE OF THE SCOPE AT THE END OF THE PROCEDURE. THE SALES REPRESENTATIVE FOR THE PRODUCT WAS CONTACTED AND THE PLAN WILL BE TO RETURN THE SCOPE FOR INSPECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743499 ↗
• MalfunctionJul 25, 2025Poor Quality Image; Poor Quality Image

  THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) THAT, "URETERO1, DISPOSABLE FLEXIBLE URETEROSCOPE IMAGE GETS CUT OFF, INTERMITTENTLY LOST AND KEEPS CUTTING OUT OR FLICKERING. OR TEAM FOUND A CRACK AT THE BASE OF THE SCOPE AT THE END OF THE PROCEDURE. THE SALES REPRESENTATIVE FOR THE PRODUCT WAS CONTACTED AND THE PLAN WILL BE TO RETURN THE SCOPE FOR INSPECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612789 ↗
• MalfunctionJul 17, 2025Erratic or Intermittent Display; Defective Device

  DEFECTIVE URETERO1 FLEXIBLE URETEROSCOPE. DOCTOR WAS USING THE URETERO1FLEXIBLE URETEROSCOPE AND HAD BEEN WORKED FINE. BUT SUDDENLY, THE IMAGE WAS LOST AND THE SCREEN SAID, "SCOPE NOT DETECTED." WE CHANGED TO ANOTHER MONITOR, BUT SAME MESSAGE SHOWED. THE PROCEDURE WAS ALMOST FINISHED AT THAT TIME; HE DIDN'T NEED ANOTHER URETERO1. THE PATIENT HAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530184 ↗
• MalfunctionJun 30, 2025Crack; Erratic or Intermittent Display

  URETERO1, DISPOSABLE FLEXIBLE URETEROSCOPE IMAGE GETS CUT OFF, INTERMITTENTLY LOST AND KEEPS CUTTING OUT OR FLICKERING. OPERATING ROOM TEAM FOUND A CRACK AT THE BASE OF THE SCOPE AT THE END OF THE PROCEDURE. THE SALES REPRESENTATIVE FOR THE PRODUCT WAS CONTACTED AND THE PLAN WILL BE TO RETURN THE SCOPE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352625 ↗
• MalfunctionMar 15, 2024Signal Artifact/Noise; Signal Artifact/Noise

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE THERE WAS INTERMITTENT VIDEO INTERFERENCE TO THEIR URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE. THERE WAS A DELAY IN THE PROCEDURE TO SWITCH TO A DIFFERENT SCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918441 ↗