INNER SHEATH FOR 27050 SC
Received May 22, 2023
Report 9610617-2023-00639 · MDR key 16974008
Device
Generic name
Inner Sheath For 27050 Sc
Manufacturer
Karl Storz Se & Co. KgModel number
27050CACatalog number
27050CA
Lot number
NR02
Product problems
- Fracture
- Fracture
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TIP CERAMIC TIP FROM SHEAT 27050 SC HAS BROKEN OUT DURING THE OPERATION. NO FURTHER INFORMATION RECEIVED.
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 CERAMIC TIP HAS BROKEN OFF OVER THE EDGE OF THE TUBE. THE FRACTURE SURFACES ARE NOT DISCOLORED. THE BONDING IS INTACT. THE SHANK WAS PRESUMABLY MECHANICALLY PRE-DAMAGED. THE PRE-DAMAGE MUST HAVE OCCURRED NOT TOO FAR APART IN TIME, AS THE FRACTURE SURFACES DO NOT SHOW ANY DISCOLORATION. THERE IS NO INDICATION FOR A MATERIAL / MANUFACTURING PROBLEM. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).