INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

AS THE DEVICE IN QUESTION WAS NOT RETURNED BY THE CUSTOMER, AN INVESTIGATION ON THE PRODUCT ITSELF COULD NOT BE PERFORMED. HOWEVER, THE AVAILABLE INFORMATION HAS BEEN REVIEWED. THE INVESTIGATION WAS COMPLETED ON 2024-06-25. ACCORDING TO THE CUSTOMER, THE CERAMIC BEAK BROKE DURING THE PROCEDURE. IT IS VERY LIKELY THAT THE ITEM HAS DEVELOPED THIS DEFECT DUE TO THE USED LIFE CYCLE SINCE MANUFACTURING (ACCORDING TO THE LOT --> OCTOBER 2016) AND POSSIBLE SIGNS OF USE SUCH AS DAMAGE TO THE SHAFT. IN ADDITION, THE DAMAGE MAY HAVE BEEN CAUSED BY EXCESSIVE FORCE DURING USE OR BY WEAR AND TEAR. IN THIS CONTEXT, THE IFU POINTS OUT THAT DAMAGE TO THE SHAFT CAN HAVE A NEGATIVE EFFECT ON THE CERAMIC BEAK. FOR THIS REASON AND ACCORDING TO THE IFU, THE USER SHOULD CHECK THE CERAMIC COMPONENTS FOR DAMAGES SUCH AS CRACKS, CHIPPING ETC. BEFORE EACH USE. THE DEVICE HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. THE ROOT CAUSE OF THE REPORTED ISSUE CAN MOST LIKELY BE TRACED BACK TO A USAGE-RELATED FAILURE. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A FRACTURE/DETACHMENT OF THE CERAMIC TIP FROM THE SLEEVE OF THE RESECTOR DURING THE PATIENT'S PROCEDURE. FIRST INTERVENTION ON (B)(6) 2023 FOR A HOLEP, AND RE-INTERVENTION OF THE PATIENT IN (B)(6) 2024, AS A CERAMIC TIP BROKE OFF AND REMAINED IN THE PATIENT'S BLADDER, REQUIRING FOREIGN BODY REMOVAL.