Bagley MR-6LARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821925006232), received between May 31, 2023 and Sep 2, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573104 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846794 ↗
• MalfunctionMay 22, 2026Overheating of Device

  THE URETEROSCOPE AND ACCESSORIES WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF WHEN DISCONNECTING THE TWO PIECES, IT WAS EXTREMELY DIFFICULT TO SEPARATE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BURN FIBERS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262350 ↗
• MalfunctionApr 3, 2026Material Deformation; Failure to Clean Adequately

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE URETEROSCOPE AND ACCESSORIES (FLEXIBLE, RIGID) HAD WHITE FLUID IN THE DISTAL CHANNEL AND A BENT DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781612 ↗
• MalfunctionApr 1, 2026Dent in Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID PRESENTED SHARP DENT ON THE DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755471 ↗
• MalfunctionNov 7, 2025Break; Poor Quality Image; Break; Poor Quality Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BLURRY VIEW THROUGH THE SCOPE AND DAMAGE TO THE LENS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494335 ↗
• MalfunctionJul 10, 2025Material Twisted/Bent; Material Twisted/Bent

  DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED A BENT OUTER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22474751 ↗
• MalfunctionSep 16, 2024Break; No Display/Image; Break; No Display/Image

  IT WAS REPORTED THE URETEROSCOPE DISTAL TIP WAS DAMAGED AND/OR BROKEN WITH A SHARP EDGE, COULD NOT SEE THE PICTURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233737 ↗
• MalfunctionJan 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE URETEROSCOPE DISTAL TIP IS BENT. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596486 ↗
• MalfunctionMay 31, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE WAS FOUND TO HAVE A BLURRY IMAGE DURING DEVICE REPROCESSING FOLLOWING A THERAPEUTIC PROCEDURE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND DISTAL TIP DAMAGE. THERE WAS NO PATIENT INVOLVEMENT. 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 17034883 ↗