Bagley MR-6ARecalls & reported problems
Gyrus ACMI, LLC · Bagley Self-Dilating Autoclavable Semi-Rigid Ureteroscope · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821925006225), received between Feb 24, 2021 and May 23, 2026 — classified as 9 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Dent in Material1
- Failure to Clean Adequately1
- Material Twisted/Bent1
- Output Problem1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2026Break
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE FLEXIBLE/RIGID URETEROSCOPE AND ITS ACCESSORIES EXHIBITED A DENT ON THE DISTAL END FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264132 ↗MalfunctionApr 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD RED STUFF STUCK IN THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24855672 ↗MalfunctionApr 10, 2026Overheating of Device
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE OR RIGID, HAD A BURNT LIGHT GUIDE FIBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838814 ↗MalfunctionMar 30, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID EXHIBITED SHARP DENT ON DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24735601 ↗MalfunctionJan 8, 2026Output Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24007505 ↗MalfunctionDec 18, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837474 ↗MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A SEVERE BEND AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921609 ↗MalfunctionJul 5, 2024Break; Break
IT WAS REPORTED THE URETEROSCOPE'S TIP WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680015 ↗MalfunctionFeb 24, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE DISTAL TIP IS DAMAGED, BROKEN WITH A SHARP EDGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED ON THIS EVENT. NO USER INJURY REPORTED.
Patient problems: No Patient Involvement
MAUDE report 11371822 ↗
Other Ureteroscope and accessories, flexible/rigid devices
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.