n.a. 27001LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551231210), received between Jun 25, 2026 and Aug 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Optical Distortion” (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-1057-2025 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Optical Distortion

  Patient problems: Insufficient Information

  MAUDE report 50166608 ↗
• MalfunctionJun 25, 2026Poor Quality Image

  IT WAS REPORTED THAT DURING THE USE OF URETEROSCOPE, THE EXTERNAL IMAGE WAS BLURRED WITH UNCLEAR VISION. IT WAS CONFIRMED THAT THE SURGERY WAS COMPLETED SMOOTHLY AFTER EQUIPMENT REPLACEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623539 ↗