RESECTOSCOPE SHEATH, 24 FR.

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 THERE WAS A REMOVAL OF A CERAMIC TIP AFTER STERILIZATION; THE CANNULA LOST ITS CERAMIC TIP IN THE BLADDER DURING THE PROCEDURE. BASED ON THE CURRENT INFORMATION SITUATION IT IS NOT CLEAR WHETHER BOTH MENTIONED ERROR DESCRIPTIONS / PRODUCTS ARE RELATED TO EACH OTHER. PRESUMABLY THESE ARE TWO DIFFERENT COMPLAINTS.

Additional Manufacturer Narrative

THE COMPLAINED 27241BO, LOT RV03 WAS RECEIVED ON 2024-10-23 AT THE MANUFACTURING SITE AND WAS THEREFORE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED ON 2024-11-07. DURING THE INSPECTION, THE FOLLOWING WAS FOUND: THE ARTICLE WITH BATCH NUMBER RV03 SHOWS A LOOSENED CONNECTION BETWEEN THE CERAMIC TIP AND THE SHAFT. IT IS STRIKING THAT THERE IS HARDLY ANY ADHESIVE RESIDUE ON THE CERAMIC TIP OR IN THE SHAFT. THE WEAKENING OF THE CONNECTION COULD BE RELATED TO AGE AND THE REPEATED REPROCESSING CYCLES. THE MANUFACTURER'S CODE INDICATES AN AGE OF 10 YEARS, WHICH MEANS THAT THE ADHESIVE COULD HAVE BEEN WASHED OUT BY NUMEROUS CLEANING AND DISINFECTION PROCESSES. THIS CAN CAUSE THE CONNECTION TO LOOSEN AND THE CERAMIC TIP TO FALL OUT. IT IS THEREFORE RECOMMENDED THAT THE INSTRUCTIONS FOR USE (IFU) AND THE INSTRUCTIONS FOR REPROCESSING BE CAREFULLY FOLLOWED AND THAT A THOROUGH INSPECTION OF THE ARTICLE IS CARRIED OUT BEFORE EACH USE TO ENSURE FUNCTIONALITY AND SAFETY. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF THE EXAMINATION, THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. THE ROOT CAUSE OF THE REPORTED ISSUE CAN BE TRACED BACK TO WEAR AND TEAR. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

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 2024-09-13. THE CUSTOMER STATES THAT THE ARTICLE 27242BO WITH THE LOT RV03 HAS LOST THE CERAMIC TIP DURING THE OPERATION IN THE BLADDER. AFTER CHECKING THE MANUFACTURING DATE, IT WAS DETERMINED THAT THE LOT RV03 WAS MANUFACTURED IN APRIL 2014. THEREFORE, IT CANNOT BE RULED OUT THAT THE SERVICE LIFE OF THE ITEM HAS BEEN REACHED AND EXCEEDED DUE TO THEIR AGE. THE REPROCESSING INSTRUCTIONS STATE UNDER POINT 11 LIFE SPAN: "THE END OF THE PRODUCT SERVICE LIFE IS LARGELY DETERMINED BY WEAR, THE REPROCESSING PROCESS, THE CHEMICALS USED, AND ANY DAMAGE CAUSED BY USE." THE IFU AND REPROCESSING INSTRUCTIONS ALSO STATE THAT A FUNCTIONAL CHECK SHOULD BE CARRIED OUT BEFORE USE. BASED ON THE ABOVE, IT IS THEREFORE ASSUMED THAT WEAR AND TEAR DUE TO THE AGE OF THE INSTRUMENT IS THE MOST PROBABLE CAUSE. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).