WHEN THE HOSPITAL INTRODUCED SOMETHING IN THE TROCAR, THE OPENING OF THE VALVE BROKE AND PIECES OF IT WENT THROUGH THE TROCAR INTO THE PT. IT WAS THE BEGINNING OF THE OPERATION WHEN THE TROCAR WAS BROUGHT IN. THEY ONLY TOOK IT OUT OF THE PACKAGING AND THEY STICK THE SHARP TIP THROUGH THE TROCAR TO BE ABLE TO INSERT IT. THERE WERE NO INSTRUMENTS USED AT THAT MOMENT. THEY HAD NOT NOTICED THAT THERE WERE SOME FLAPS BROKEN OFF THE VALVE SO THEY THINK IT HAPPENED AT THE MOMENT THEY INSERTED THE TROCAR. AFTER INSPECTION OF THE THORAX THEY SAW A PIECE OF THE SILICONE FLAP LYING THERE.
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Patient 1
THE 12 MM HUNT SECONDARY CANNULA/PYRAMIDAL TROCAR USED IN EVENT WAS NOT RETURNED TO COOPERSURGICAL FOR EVAL - THE CUSTOMER STATED THEY NO LONGER HAVE IT. THE CUSTOMER DID RETURN THE REDUCER FOR EVAL. BY DESIGN - THE CENTER OF EACH REDUCER IS SLIT INTO 3 SECTIONS TO ALLOW INSERTION OF THE TROCAR. THE RETURNED REDUCER HAD ONE-THIRD REMAINING ATTACHED AND THE OTHER TWO THIRDS WERE CONNECTED ONLY TO EACH OTHER. INCOMING INSPECTION FOR THIS COMPONENT'S LOT HAS BEEN REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE LOT HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED DURING IN-PROCESS OR FINAL INSPECTIONS. A REVIEW OF THE COMPLAINT DATABASE SHOWS NO SIMILAR COMPLAINTS OR TREND. ALTHOUGH THIS IS AN ISOLATED INCIDENT THE REDUCER SUPPLIER IS BEING CONTACTED TO DETERMINE WHETHER THEY HAVE SEEN SIMILAR DISCREPANCIES DURING PRODUCTION. FURTHER INFO TO BE OBTAINED FROM SUPPLIER TO DETERMINE IF ADD'L ACTION IS NECESSARY. IF SO THE COMPLAINT INVESTIGATION WILL BE UPDATED ACCORDINGLY AND A F/U REPORT WILL BE SUBMITTED TO FDA. (B)(4).