InjuryFBO
FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE
Received Dec 21, 2023
Report 2020550-2023-00399 · MDR key 18375032
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz EndovisionModel number
11272C1Catalog number
11272C1
Product problems
- Calcified
- Calcified
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FRONT COVER OF THE PRODUCT (DEFECTIVE). INFECTIONS OCCURRED SEVERAL TIMES AFTER ENDOSCOPY. DUE TO THE REPORTED POSSIBLE INFECTIONS (CAUSALITY NOT CONFIRMED) THE RISK FOR SERIOUS DETERIORATION IN STATE OF HEALTH IS NOT NEGLIGIBLE.