Bagley REXMR-6ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925007826), received between Jun 22, 2021 and Apr 26, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THE URETEROSCOPE'S TIP WAS DAMAGED, AND IT WAS SHARP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192259 ↗
• MalfunctionJul 26, 2022Sharp Edges; Sharp Edges

  CUSTOMER REPORTED WITH AN ISSUE OF "ROUGH PLACE ON END OF SHAFT HAS BURR". THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107042 ↗
• InjuryJun 9, 2022Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A SEMI RIGID URETEROSCOPE, THE SCOPE GOT HOT WHEN CONNECTED TO THE LIGHT CORD AND THE PATIENT EXPERIENCED A BURN ON HIS PENIS. THE SEVERITY OF THE BURN IS UNKNOWN. IT IS UNKNOWN IF WHAT/IF THE PATIENT REQUIRED ANY TREATMENT OR INTERVENTION FOR THE BURN. ADDITIONAL DETAILS HAVE BEEN REQUESTED FROM THE CUSTOMER, AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 14644865 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT THE SCOPE IS DAMAGED. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE RETURN EVALUATION FOUND THE OUTER TUBE AT THE DISTAL TIP OF THE DEVICE WAS DAMAGED WITH A SHARP EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167743 ↗
• MalfunctionJun 22, 2021Sharp Edges; Sharp Edges

  THE SERVICE CENTER WAS INFORMED THAT A CUSTOMER URETEROSCOPE, 33CM WAS RETURNED DUE TO A REPORT OF "POOR VISIBILITY". UPON INSPECTION AND TESTING, THE DISTAL END OF THE OUTER TUBE WAS OBSERVED TO BE DENTED AND SHARP. NO PATIENT HARM OR INVOLVEMENT WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041313 ↗