INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

REQUEST WAS MADE AND THE REPORTED DEVICE IS PENDING RETURN FOR EVALUATION. ONCE THE REPORTED DEVICE IS RETURNED AND THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WOULD BE MADE TO THE FDA. THIS COMPLAINT WILL BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A SMALL PIECE OF THE BLUE LIGHT RESECTION SCOPE BROKE OFF INSIDE PATIENT'S BLADDER DURING TRANSURETHRAL RESECTION OF A BLADDER TUMOR. DURING THE SURGERY, A PLASTIC COMPONENT OF THE RESECTOSCOPE BROKE OFF. THE SURGEON HAD TO SWITCH TO A CYSTOSCOPE AND RETRIEVE THE PIECE USING A GRASPER. THE PIECE WAS REMOVED THROUGH PATIENT'S URETHRAL LUMEN. THERE WAS NO REPORT OF INJURY TO THE PATIENT. IT WAS CONFIRMED THAT NOTHING WAS LEFT INSIDE THE PATIENT.

Additional Manufacturer Narrative

PER EVALUATION FINDINGS BY THE MANUFACTURING SITE: THE RETURNED PRODUCT DOES NOT CONTAIN ANY BLUE PLASTIC PARTS. THEREFORE, THE FRAGMENT CANNOT HAVE DETACHED FROM THE CLAIMED SHAFT (27050CA). AFTER INQUIRING WITH KSEA WHETHER OTHER KARL STORZ PRODUCTS WERE INVOLVED IN THE INCIDENT, THIS WAS DENIED (EVEN AFTER INQUIRIES AT THE CUSTOMER). NO MISSING PARTICLE CAN BE RECOGNIZED ON THE SHAFT. IT CAN THEREFORE BE ASSUMED THAT ANOTHER, UNKNOWN PRODUCT WAS DAMAGED. WHEN INSTALLING THE CERAMIC INSERTS, COLORS BETWEEN RAL7036 AND RAL7043 ARE USED, THESE ARE SIGNIFICANTLY DARKER THAN THE ONE INSTALLED ON THE SHAFT THAT IS THE SUBJECT OF THE COMPLAINT, THEREFORE A THIRD-PARTY REPAIR CANNOT BE RULED OUT. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).