INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0052 CORRECTIVE ACTION 6. UPON EXAMINATION WE FOUND THAT THE CERAMIC TIP IS BROKEN OUT. THE CERAMIC INSERT HAS NOT BEEN PROVIDED. THERE WAS SUFFICIENT GLUE BETWEEN TIP AND SHEATH, BECAUSE THE BONDED CERAMIC STILL ADHERES WELL IN THE INNER PART OF THE SHEATH. THE SHEATH SHOWS PROXIMAL CORROSION, WHICH CAN BE ATTRIBUTED TO INCORRECT CLEANING. DAMAGES LIKE THIS HAPPEN IF THE CERAMIC INSERT IS HIT AGAINST HARD OBJECTS OR EDGES. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE TIP WAS BROKEN OFF DURING SURGERY. A SECOND SURGERY WAS NEEDED TO REMOVE THE BROKEN PART.