RESEKTOSKOPSCHAFT, 26 CHARR., SET

Additional Manufacturer Narrative

DEVICE EVALUATION: SINCE THE AFFECTED PRODUCT WAS NOT RETURNED TO KARL STORZ TUTTLINGEN, NO PHYSICAL EXAMINATION COULD BE CARRIED OUT. THE ANALYSIS IS BASED ON HISTORICAL AND TREND ANALYSIS AND THE CUSTOMER'S DESCRIPTION OF THE INCIDENT. IT IS ASSUMED THAT THE DAMAGED PART IS THE CERAMIC TIP OF THE 26040XA ITEM. IT WAS NOT POSSIBLE TO IDENTIFY THE EXACT PRODUCT DUE TO THE LACK OF A RETURN SHIPMENT. THE POSSIBLE CAUSE OF THE CERAMIC TIP BREAKING CAN BE ATTRIBUTED TO VARIOUS FACTORS: REPEATED APPLICATIONS CAN CAUSE MATERIAL FATIGUE, RESULTING IN MICROCRACKS THAT ULTIMATELY LEAD TO BREAKAGE. EXCESSIVE USER FORCE ON THE CERAMIC TIP CAN CAUSE MICROCRACKS TO FORM, WHICH EXPAND OVER TIME AND EVENTUALLY LEAD TO BREAKAGE. THIS IS CONSISTENT WITH THE WARNING STATEMENTS IN THE IFU REGARDING OVERLOADING AND CARELESS HANDLING OF CERAMIC COMPONENTS. IF THE CERAMIC TIP WAS ALREADY DAMAGED PRIOR TO USE OR IMPROPERLY REPROCESSED, THIS COULD HAVE CONTRIBUTED TO THE WEAKENING OF THE MATERIAL. THE INSTRUCTIONS FOR USE (IFU) AND PRESCRIBED REPROCESSING GUIDELINES SHOULD BE FOLLOWED TO ENSURE THE FUNCTION OF THE PRODUCT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE 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 THE RESECTOSCOPE INNER SHEET CERAMIC TIP GOT DAMAGED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 15 MINUTES. NO HARM TO THE PATIENT, USER OR THIRD REPORTED.