n.a. 27072FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551079263), received between Mar 3, 2021 and Jan 21, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT DURING A CYSTOSCOPY. AN X-RAY WAS TAKEN, AND IT WAS CONFIRMED THAT ALL PIECES COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21204511 ↗
• InjuryJan 21, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT DURING A CYSTOSCOPY. AN X-RAY WAS TAKEN, AND IT WAS CONFIRMED THAT ALL PIECES COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21204507 ↗
• MalfunctionMar 3, 2021Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: DURING A REMOVAL OF A BLADDER STONE, A SCREW BROKE OFF AND 3 METAL PARTICLES FELL IN THE BLADDER DUE TO WHICH THEY WERE LABORIOUSLY REMOVED. THE SURGERY TIME WAS EXTENDED BY 30 MINUTES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408002 ↗