CYSTO-URETHRO-FIBERSCOPE
Received Jul 8, 2025
Report 9610617-2025-01140 · MDR key 22439546
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz Se & Co. KgModel number
8404ZXKCatalog number
8404ZXK
Product problems
- No Display/Image
- Insufficient Device Problem Information
- No Display/Image
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE C-MAC MONITOR FREEZES. NO NEGATIVE IMPACT ON STATE OF HEALTH REPORTED.
Additional Manufacturer Narrative
RESULT OF INVESTIGATION: AS THE CLAIMED PRODUCT WAS NOT RETURNED FOR INSPECTION, A MORE DETAILED INVESTIGATION IS NOT POSSIBLE. THE DEVICE PASSED THE QUALITY TEST AT THE TIME OF DELIVERY. BASED ON THE CUSTOMER'S DESCRIPTION OF THE FAULT (MONITOR FREEZES), WE ASSUME THAT IT WAS CAUSED BY USER ERROR, AS THE IFU STATES THAT THE PRODUCT MUST BE CHECKED FOR FUNCTIONALITY BEFORE USE, WHICH WOULD HAVE PREVENTED THIS FAULT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).