16 FR. FLEXIBLE VIDEO CYSTOSCOPE
Received May 20, 2020
Report 1221826-2020-00059 · MDR key 10077291
Device
Product problems
- Contamination /Decontamination Problem
- Microbial Contamination of Device
- Contamination /Decontamination Problem
Patient
Not reported
- Unspecified Infection
- Patient Problem/Medical Problem
- Unspecified Infection
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
RECEIVED TESTING RESULTS AND 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 48MM FROM SHAFT ADAPTER AND THE VERTEBRAE SYSTEM IS CRUSHED 30MM FROM DISTAL TIP. UNABLE TO CONFIRM CUSTOMER'S COMPLAINT. ICH WAS PENDING THE UPDATES.
Additional Manufacturer Narrative
WE RECEIVED THE SCOPE FROM THE CUSTOMER AND ARE WORKING ON A MICROBIOLOGICAL ASSESSMENT ON RECOVERED ORGANISMS. WHEN THE ASSESSMENT RESULT IS READY WE WILL FILE A SUPPLEMENT REPORT, WHICH WE EXPECT WILL BE EARLY JUNE.
Description of Event or Problem
ALLEGEDLY, THE FLEXIBLE CYSTOSCOPE WAS USED IN 4 CASES AND THE CLINIC REPORTS 2 PATIENTS CONTRACTED AN INFECTION.