Description of Event or Problem · 1
A PATIENT WAS UNDERGOING LAPAROSCOPIC HERNIA REPAIR. WHEN REACHING FOR A SUTURE WITH GRASPERS, THE TIP OF THE 12MM CANNULA (VS101512P) BROKE. UPON REMOVAL OF THE 5MM CANNULA (VS101505), IT WAS NOTED THAT THE TIP OF THIS CANNULA WAS BROKEN AS WELL. THE SURGEON WAS UNABLE TO LOCATE THE BROKEN PIECES INSIDE THE PATIENT. SUTURE GRASPERS WERE BEING USED THROUGH THE VERSASTEP PLUS 12MM CANNULA. THIS CANNULA WAS BEING USED WITH A VERSASEAL PLUS (175772P), TO ACCOMMODATE INSTRUMENTS FROM 5MM - 12MM. WHEN REACHING FOR A SUTURE, THE GRASPERS WERE FORCED AGAINST THE WALL OF THE CANNULA AND THE TIP OF THE CANNULA BROKE. THERE ARE 3 CRACKS IN THE DISTAL TIP OF THE CANNULA, EACH APPROXIMATELY 6MM LONG. THERE ARE 2 PIECES OF THE CANNULA THAT ARE MISSING. ONE PIECE IS APPROXIMATELY 2.25MM LONG X 1MM WIDE. THE OTHER PIECE IS APPROXIMATELY 3MM WIDE, WITH AN IRREGULAR LOWER EDGE. THIS PIECE IS APPROXIMATELY 2.75MM LONG FOR 1MM, AND THEN 1.5MM LONG FOR THE REMAINING 2 MM. THE CRACKS COVER ABOUT 1/3 OF THE CIRCUMFERENCE OF THE DISTAL TIP OF THE CANNULA. THERE IS NO VISIBLE DAMAGE INSIDE OF THE CANNULA. THE EXPIRATION DATE ON THE PACKAGE WAS FEBRUARY 2006. IT IS NOT KNOWN WHAT TYPE OF INSTRUMENT WAS BEING USED IN THE 5MM CANNULA (VS101505). THE SURGEON WAS NOT AWARE THAT THIS CANNULA HAD BROKEN DURING THE PROCEDURE. WHEN THE CANNULA WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE CANNULA HAD BROKEN AT THE DISTAL END. THERE ARE 3 CRACKS IN THE DISTAL END. 2 CRACKS ARE APPROXIMATELY 2.5MM LONG AND THE THIRD CRACK IS APPROXIMATELY 3.5MM LONG. THERE ARE 2 MISSING PIECES. ONE PIECE IS APPROXIMATELY 1MM LONG BY 2MM WIDE. THE OTHER PIECE IS APPROXIMATELY 4MM LONG BY 2MM WIDE. THE CRACKS COVER ABOUT 2/3 OF THE CIRCUMFERENCE OF THE CANNULA TIP. THERE IS NO OTHER VISUAL DAMAGE TO THE CANNULA. THE EXPIRATION DATE ON THE PACKAGE OF THIS CANNULA WAS MAY 2010.