INNER SHEATH FOR 27050 SC

Description of Event or Problem

IT WAS REPORTED THAT DURING A BLADDER TUMOR RESECTION PROCEDURE ON (B)(6) 2024, A PLASTIC PIECE AT THE TOP OF THE SHEATH BROKE INSIDE OF THE PATIENT. THEY WERE ABLE TO OBTAIN THE BROKEN PIECE WITH NO DAMAGE TO TISSUES. ACCORDING TO THE CUSTOMER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON DID NOT NOTICE ABOUT THE BROKEN PIECE UNTIL HE WAS LOOKING AROUND AND GATHERING THE TUMOR FLAKES. THE DOCTOR PLACED THE PATIENT ON SEVERAL DAYS OF ANTIBITOICS DUE TO THIS AS A PRECAUTION.

Additional Manufacturer Narrative

CUSTOMER WILL NOT RETURN THE DEVICE TO US, AND THUS CANNOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT (B)(4).

Additional Manufacturer Narrative

CHANGES MADE FROM THE INITIAL REPORT: ---UPDATED THE UDI NUMBER IN SECTION D4. PER INVESTIGATION BY THE MANUFACTURING SITE: THE CONCERNED PRODUCT WAS NOT RETURNED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION WAS NOT POSSIBLE, AND THE INVESTIGATION WAS CONDUCTED BASED ON THE AVAILABLE INFORMATION. THE RECEIVED INFORMATION INDICATES THAT THE CERAMIC BEAK BROKE DURING THE PROCEDURE AND A PART FELL INTO THE PATIENT AND HAS NOT BEEN FOUND. POTENTIAL SCENARIOS LEADING TO THIS COULD BE FOR EXAMPLE THAT THE TIP WAS STRUCK, WHICH CAN LEAD TO BREAKAGE, OR THE MATERIAL WAS DAMAGED BY THERMAL IMPACT (THE ELECTRODE BURNS NEAR THE CERAMIC INSERT). AN APPLICATION ERROR IS ASSUMED AS THE MOST PROBABLE CAUSE. IN THIS CONTEXT, THE IFU POINTS OUT THAT DAMAGE TO THE SHAFT CAN HAVE A NEGATIVE EFFECT ON THE CERAMIC BEAK. THE INSTRUCTIONS FOR USE THEREFORE STATE THAT YOU SHOULD CHECK THE CERAMIC COMPONENTS FOR DAMAGE SUCH AS CRACKS, CHIPPING ETC. BEFORE EACH USE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).