INNER SHEATH FOR 27050 SC
Received May 22, 2023 · Event occurred Jan 11, 2019
Report 9610617-2023-00642 · MDR key 16974012
Device
Generic name
Inner Sheath For 27050 Sc
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
OW01
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. THE AFFECTED PRODUCT HAS NOT BEEN RETURNED BECAUSE IT WAS SCRAPPED BY THE USER. THEREFORE NO DEVICE INVESTIGATION CAN BE PERFORMED. NO ROOT CAUSE CAN BE DETERMINED. A COMPLAINT ANALYSIS SHOWED THAT CASES WITH SIMILAR FAILURE DESCIRPTION WERE CAUSED BY MECHANICAL OVERLOAD OR MECHANICAL DAMAGE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE END OF THE SHEATH BROKE INSIDE THE PATIENT. OPERATION EXTENDED. USE OF ADDITIONAL ITEMS NOT REQUIRED TO REMOVE THE PART OF SHEATH.