PELION SURGICAL GALIB SIDEPORT INSTRUMENT,STANDARD KNURLED HANDLE

Description of Event or Problem

PATIENT ADMITTED TO SURGERY CENTER FOR CATARACT SURGERY. DURING PROCEDURE SURGEON WAS USING A PELION SURGICAL GALIB SIDEPORT INSTRUMENT TO BREAK UP THE CATARACT. IN THE PROCESS, SURGEON WAS INSPECTING THE INSTRUMENT AND NOTED A SMALL FRAGMENT OF THE SIDEPORT HAD BROKEN OFF INTO PATIENTS EYE. SURGEON WAS SUCCESSFUL AT EXTRACTING THE PIECE OF INSTRUMENT. NO COMPLICATIONS HAD OCCURRED BECAUSE OF THE BROKEN FRAGMENT. PELION SURGICAL REPRESENTATIVE WAS NOTIFIED OF DAMAGED DEVICE. INSTRUMENT BEING RETURNED TO MANUFACTURER FOR FURTHER INVESTIGATION.