INNER SHEATH FOR 27050 SL

Description of Event or Problem

BREAKDOWN OF THE DISTAL PART OF THE ROTATORY SHIRT MOVEMENT AND ITS DETACHMENT IN THE OPERATING CHANNEL.

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 12. UPON EVALUATION PARTS OF THE CERAMIC TIP WERE FOUND TO BE BROKEN OFF. THE BROKEN OFF PARTS WERE NOT RETURNED. A FULL THICKNESS CRACK WITH CHIPPING ON THE EDGE WAS DISCOVERED AT THE TIP. THERE IS A RING OF DISCOLORATION VISIBLE WHICH SUSPECTS THERMAL DAMAGE. MOST LIKELY AN INITIAL CRACK WAS INDUCED BY HITTING THE OBJECT AGAINST AN OTHER OBJECT. CRACKS CAN GROW OVER TIME, MATERIAL STRESS DUE TO HEAT CHANGE CAN ACCELERATE THE PROCESS. THE DEVICE WAS MANUFACTURED IN APRIL 2016. THE ROOT CAUSE MOST LIKELY WAS A HIGH FORCE IMPACT WHICH LED TO A CRACK AND FINALLY TO THE BREAK OF THE CERAMIC TIP. SHEATHS WITH CERAMIC TIPS MUST BE HANDLED CAREFULLY. THE SHEATHS MUST BE CHECKED FOR CRACKS OR OTHER DAMAGES ACCORDING TO THE IFU. NO INDICATION FOR A MATERIAL OR MANUFACTURING RELATED ISSUE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ((B)(4)).