MalfunctionFBO
FLEXIBLE CYSTONEPHROSCOPE-T
Received May 27, 2026 · Event occurred Apr 1, 2026
Report 3011050570-2026-00582 · MDR key 25304472
Device
Product problems
- Contamination /Decontamination Problem
Patient
21 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BIOBURDEN WAS SEEN COMING OUT OF THE FLEXIBLE CYSTONEPHROSCOPE-T. THE ISSUE WAS FOUND UPON THE START OF A THERAPEUTIC CYSTOSCOPY. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.