n.a. 27011LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551231371), received between Feb 28, 2019 and Feb 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

   Z-1058-2025 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2019Material Frayed; Material Frayed

  URETEROSCOPE WAS PLACED INTO URETER AND ADVANCED TOWARD THE KIDNEY. DURING REMOVAL, THE URETER STUCK TO SCOPE AND WAS AVULSED. THE URETER COULD NOT BE REPAIRED AND A NEPHRECTOMY WAS PERFORMED.

  Patient problems: Excessive Tear Production; Patient Problem/Medical Problem

  MAUDE report 8379098 ↗