INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OUR US FACILITY ON FEBRUARY 18, 2025. IT WILL 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 ID (B)(4).

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2025, DURING A TURB PROCEDURE, THE CERAMIC BEAK OF SHEATH BROKE OFF OF INSTRUMENT INSIDE THE PATIENT AND NEEDED TO BE RETRIEVED WITH OTHER AVAILABLE INSTRUMENTATION. NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

PER INVESTIGATION BY THE MANUFACTURING SITE: AFTER CAREFUL ANALYSIS OF THE AVAILABLE INFORMATION AND CONSIDERING THE INSTRUCTIONS FOR USE, IT CAN BE ASSUMED THAT THE BREAKAGE OF THE CERAMIC TIP DURING THE SURGICAL PROCEDURE WAS DUE TO A MULTIFACTORIAL PROCESS. THE MOST LIKELY CAUSE IS AN APPLICATION ERROR IN WHICH THE TIP WAS MECHANICALLY OVERLOADED. IN ADDITION, THERMAL INFLUENCES - SUCH AS INSUFFICIENT DISTANCE BETWEEN THE ELECTRODE AND THE CERAMIC INSERT - MAY HAVE WEAKENED THE MATERIAL. THE INSTRUCTIONS FOR USE EXPRESSLY POINT OUT THAT CERAMIC IS A BRITTLE MATERIAL THAT IS SENSITIVE TO MECHANICAL AND THERMAL STRESS. EVEN THE SMALLEST, INITIALLY INVISIBLE MICROCRACKS CAN GROW THROUGH REPEATED STRESS (E.G., CLEANING, STERILIZATION) AND EVENTUALLY LEAD TO BREAKAGE. INADEQUATE VISUAL INSPECTION PRIOR TO USE AND POSSIBLE PRE-EXISTING DAMAGE FROM PREVIOUS CYCLES MAY HAVE FURTHER CONTRIBUTED TO THE DAMAGE. OVERALL, EVERYTHING INDICATES THAT A COMBINATION OF MECHANICAL STRESS, POSSIBLE THERMAL INFLUENCES, AND INADEQUATE INSPECTION PRIOR TO THE PROCEDURE LED TO THE FAILURE OF THE CERAMIC TIP. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).