n.a. 496URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551169629), received between Oct 23, 2018 and Aug 16, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2019Use of Device Problem; Use of Device Problem

  ALLEGEDLY, THE PATIENT SUSTAINED BURNS DURING A PROCEDURE. THE CUSTOMER BELIEVES THE BURNS ORIGINATED AT THE CONNECTIONS OF THE FIBER OPTIC ILLUMINATING URETER PROBES TO THE BIFURCATED FIBER OPTIC LIGHT CABLE, WHICH WERE USED DURING THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 8903789 ↗
• MalfunctionJan 31, 2019Device Contamination with Body Fluid

  ALLEGEDLY, AFTER A PROCEDURE, BLOOD/BODILY FLUID WAS NOTED INSIDE OF THE URETER PROBE UPON RETURN FOR REPROCESSING, WHICH COULD HAVE POSSIBLY RESULTED IN CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8295086 ↗
• InjuryOct 23, 2018Use of Device Problem; Use of Device Problem

  ALLEGEDLY, DURING A PROCEDURE, THE PATIENT'S LEG WAS BURNED BY THE PROXIMAL END OF THE URETER PROBE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7997853 ↗