INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 12. UPON EVALUATION IT COULD BE CONFIRMED THAT THE CERAMIC TIP IS BROKEN OFF. THE SHEATH SHOWS RESIDUALS OF THE ADHESIVE WERE THE CERAMIC IS BROKEN OFF. THE TIP SHOWS A CONTINUOUS CRACK AND CERAMIC CHIPPING NEAR THE EDGE OF THE TIP. THE BREAK LINE STARTS AT THE EDGE OF THE TIP AND CONTINUES IN CIRCULAR WAY IN THE GLUING AREA. THE EDGE OF THE TIP SHOWS DISCOLORATION. THE ROOT CAUSE MOST LIKELY WAS MECHANICAL DAMAGE TO THE CERAMIC TIP WHICH LED TO THE CRACK AND SUBSEQUENT TO THE BREAKAGE. NO INDICATION FOR A MATERIAL OR MANUFACTURING RELATED ISSUE WAS FOUND DURING THE INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A BEAK HAS BROKEN OFF INSIDE THE BLADDER OF THE PATIENT ON ONE OF THE CUSTOMER OWNED RESECTOSCOPE SETS. THE SURGEON WAS ABLE TO RETRIEVE THE BEAK ENTIRELY BUT THE PATIENT SUFFERED SOME MILD URETHRAL TRAUMA AS A RESULT.