SureFlex 8013060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953000152), received between Dec 12, 2017 and Dec 12, 2017 — classified as 1 malfunction.

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

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

• MalfunctionDec 12, 2017Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE SURGICAL FIBER WAS NOTED TO HAVE BROKEN INSIDE OF THE SCOPE, UPSTREAM OF THE SITE OF INTERVENTION, ¿CAUSING A BURNING PAIN IN THE SURGEON¿S HAND¿. NO SUBSEQUENT TREATMENT OR INJURY OF THE SURGEON WAS REPORTED. THE SURGICAL FIBER AND SCOPE WERE EXCHANGED RESULTING IN A SLIGHT DELAY IN COMPLETING THE PROCEDURE. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7109502 ↗