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 6. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4). UPON THE EVALUATION IT COULD BE CONFIRMED THAT THE CERAMIC BEAK IS BROKEN OFF. A YELLOW DISCOLORATION AT THE ADHESIVE IS VISIBLE, WHICH IS CAUSED BY SEVERAL APPLICATIONS. THE SURFACE SHOWS SCRATCHES AND DENTS. IN ADDITION, THE OBVERSE SURFACE IN THE FLARED, DISTAL AREA IS SHINY, WHICH INDICATES THAT THE INNER SHAFT IS IN CONTACT WITH THE OURTER SHAFT. THE ROOT CAUSE FOR THE BREAKAGE OF THE CERAMIC BEAK IS MOST LIKELY, THAT THE INNER SHAFT WAS SLIGHTLY CANTED, WHICH EXERTED TOO MUCH FORCE ON THE CERAMIC TIP. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS EVENT WITH A "INNER SHEATH". ACCORDING TO THE INFORMATION RECEIVED: DURING ENDOSCOPIC RESECTION OF A BLADDER TUMOR, THE SMALL PIECE OF BAKELITE ATTACHED TO THE END OF THE SIMPLE SHEATH OF THE STORZ BIPOLAR RESECTOR BROKE AND BECAME DETACHED INSIDE THE BLADDER. THE DOCTOR WAS FORCED TO USE A CYSTOSCOPE AND FOREIGN BODY FORCEPS IN ORDER TO EXTRACT THE PIECE OF MATERIAL. NO CLINICAL CONSEQUENCES. FURTHER INFORMATION IS NOT AVAILABLE.