INNER SHEATH FOR 27050 SL
Received May 31, 2023 · Event occurred Jul 25, 2018
Report 9610617-2023-00651 · MDR key 17031024
Device
Generic name
Inner Sheath For 27050 Sl
Manufacturer
Karl Storz Se & Co. KgModel number
27050XACatalog number
27050XA
Lot number
YS08
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT IT CAME TO A BREAKAGE OF THE INNER SHEATH. THE BROKEN PART WAS FORCED INTO THE PATIENT'S BLADDER BY THE FLUSHING AND HAD TO BE RECOVERED.
Additional Manufacturer Narrative
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 12. THE STEM HAS BEEN KINKED - ALL THE MILLED HOLES TOWARDS THE FLUSHING CONNECTION HAVE BEEN BROKEN THROUGH. THE CERAMIC BEAK IS BROKEN - THE BROKEN SURFACES ARE NOT DISCOLORED. VARIOUS NOTCHES CAN BE SEEN ON THE BAYONET. THE SHAFT WAS BENT BY FORCE. THE CERAMIC BEAK WAS ALSO DAMAGED. BASED ON THE SIGNS OF USE ON THE BAYONET, IT CAN BE ASSUMED THAT IT WAS USED FREQUENTLY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).