INNER SHEATH, FOR 27050 SM

Additional Manufacturer Narrative

PER INVESTIGATION BY THE MANUFACTURING SITE: ACCORDING TO THE CUSTOMER'S DESCRIPTION, PART OF THE CERAMIC INSERT HAS BROKEN OFF. ONE POSSIBLE CAUSE FOR THIS COULD BE, FOR EXAMPLE, THAT THE CERAMIC TIP WAS DAMAGED BEFOREHAND DUE TO IMPROPER HANDLING, OR IT COULD BE A CONSEQUENTIAL ERROR DUE TO A BURNT-OUT LOOP, IN WHICH CASE THE THERMAL EFFECT COULD ALSO HAVE AN IMPACT ON THE PROPERTIES OF THE CERAMIC. HOWEVER, AS THE ITEM IS NOT AVAILABLE FOR EXAMINATION, NO MORE PRECISE STATEMENT CAN BE MADE ABOUT THE FAULT PATTERN. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THE EVENT THE DEVICE RETURNS AND RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED DURING A TURP BIOPSY PROCEDURE ON (B)(6) 2024, THERE WAS A BREAKAGE OF THE CERAMIC. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED, THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PIECE FLOATING AROUND AND THERE WAS A SURGAL DELAY OF APPROXIMATELY 25 MINUTES WHILE ATTEMPTING TO REMOVE THE BROKEN PIECES. HOWEVER, IT WAS REPORTED THAT IT'S HARD TO TELL IF THE BROKEN PIECE MAY HAVE CUT THE PATIENT ON THE WAY OUT.