CYSTO-URETHRO-FIBERSCOPE
Received May 10, 2023
Report 1221826-2023-00098 · MDR key 16904841
Device
Generic name
Flexible Fibreoptic Cystourethroscope
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
11272C1Catalog number
11272C1
Product problems
- Contamination
- Microbial Contamination of Device
- Contamination
- Microbial Contamination of Device
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INITIAL CASE FOR THIS REPORT WAS DEEMED REPORTABLE, BUT AFTER THE EVALUATION OF THE PRODUCT, IT HAS BEEN CONCLUDED THAT THERE WERE NO ISSUES WITH THE DEVICE. THE EVENT WAS RE-EVALUATED AND IS CONSIDERED NOT REPORTABLE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
THE EVENT OCCURRED IN GERMANY. THE CUSTOMER REPORTS A POSSIBLE INCIDENT DUE TO GERMS IN THE INSTRUMENT. NO DETAILS REGARDING MALFUNCTION, PATIENT INVOLVEMENT, OR NEGATIVE IMPACT ON THE STATE OF HEALTH WERE REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THIS TIME. THUS, IN TERMS OF CAUTION, THIS CASE IS DEEMED REPORTABLE.
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).