INNER SHEATH WITH CERAMIC BEAK

Additional Manufacturer Narrative

THE DEVICE WAS EVALUATED BY THE MANUFACTURER, KARL STORZ IN (B)(6). AS PER THE EVALUATION: THE BROKEN CERAMIC TIP IS CRACKED AND SHOWS SLIGHT DISCOLORATION DUE TO FIRE DAMAGE IS VISIBLE AT THE DISTAL END. THE SLIGHT DISCOLORATION INDICATES TOO HIGH/TOO LONG EXPOSURE TO HEAT. THE CERAMIC TIP HAS BEEN MECHANICALLY OVERLOADED - MOST LIKELY DROPPED AND IS WHAT PRE-DAMAGED THE CERAMIC TIP. AN INDICATOR FOR THIS IS THE CRACK FORMATION AT THE CERAMIC TIP. DAMAGES LIKE THIS HAPPEN IF THE CERAMIC INSERT IS HIT AGAINST HARD OBJECTS OR EDGES. DURING INTENDED USE, THERE IS NO POSSIBILITY TO APPLY FORCES TO ACHIEVE THE DEFECTS. THE WARNING NOTICES WITH THE CORRESPONDING PICTURES IN THE IFU INDICATE THIS.

Description of Event or Problem

AS PER A VIGILANCE REPORT FILED WITH THE (B)(6) COMPETENT AUTHORITY BY OUR PARENT COMPANY IN (B)(6) , DURING A PLANNED PROCEDURE, RESECTION OF THE PROSTATE, OUR INSTRUMENTS WERE USED. RIGHT AT THE BEGINNING OF THE PROCEDURE, THE CERAMIC TIP OF THE INNER SHAFT BECAME DETACHED. AFTER A LONG, INTENSIVE SEARCH, THE BROKEN TIP WAS RECOVERED. DUE TO SURGICAL EXTENSION, THE PATIENT WAS UNNECESSARILY EXPOSED TO ANESTHESIA.