inforMED
InjuryFBO

16 FR. FLEXIBLE VIDEO CYSTOSCOPE

Received May 11, 2022

Report 1221826-2022-00075 · MDR key 14355470

Device

Generic name

Flexible Video Cystoscope

Model number

11272VNUK

Catalog number

11272VNUK

Product problems

  • Contamination /Decontamination Problem
  • Contamination /Decontamination Problem

Patient

Unknown

  • Unspecified Infection
  • Unspecified Infection

Narrative

Additional Manufacturer Narrative

DEVICE WAS RETURNED FOR EVALUATION. PER THE MANUFACTURER'S EVALUATION FINDINGS: PER THE TESTING RESULTS, NO LINK COULD BE MADE TO THE PATIENT INFECTIONS AND ANY PERSISTENT MICROBIAL GROWTH (I.E. BIOFILM) COULD NOT BE IDENTIFIED. IT WAS FOUND THE SHAFT IS CRUSHED 48 MM FROM SHAFT ADAPTER AND THE VERTEBRAE SYSTEM IS CRUSHED 30 MM FROM DISTAL TIP. UNABLE TO CONFIRM CUSTOMER'S COMPLAINT.

Description of Event or Problem

THE FLEXIBLE CYSTOSCOPE WAS USED IN 4 CASES AND THE CLINIC REPORTS 2 PATIENTS CONTRACTED AN INFECTION. THIS REPORT IS FOR THE SECOND OF THE TWO CASES. REPORT #1221826-2020-00059 WAS PREVIOUSLY SUBMITTED FOR ONE OF THE TWO CASES.