86 HRH MEDTRONIC XOMED, INC.

SEVERAL ATTEMPTS HAVE BEEN MADE BY MEDTRONIC TO CONTACT THE RISK MGR TO INQUIRE ABOUT THE PT INFO. IF ADD'L INFO IS OBTAINED, A F/U REPORT WILL THEN BE FILED. THE CUSTOMER HAD PREPARED THREE DIFFERENT TREPHINE BLADES FOR THE PROCEDURE. ONLY ONE BLADE HAD CAUSED THE DAMAGE, BUT THE CUSTOMER WAS UNSURE WHICH TREPHINE BLADE WAS USED ON THE DONOR CORNEA. TWO SEPARATE MDRS (1045254-2010-00005 / 1045254-2010-00006) WILL BE COMPLETED FOR EACH OF THE REMAINING ITEMS. THE FACILITY RISK MGR WAS CONTACTED ABOUT THE RETURN OF THE PRODUCT. SHE STATED, SHE WILL NOT BE RETURNING THE PRODUCT UNTIL THE FACILITY HAS COMPLETED THEIR INVESTIGATION.

THE ATTENDING NURSE REPORTED DURING A CORNEAL TRANSPLANT PROCEDURE, THE DONOR CORNEA WAS DAMAGED BY THE TREPHINE BLADE AND THE PROCEDURE HAD TO BE CANCELED UNTIL THE NEXT DAY. THE TRANSPLANT WAS SUCCESSFULLY COMPLETED AND THE PT WAS DISCHARGED. BECAUSE THE PROCEDURE WAS POSTPONED, WHICH COULD HAVE CAUSED ADD'L RISK TO THE PT, THE INCIDENT IS BEING FILED AS A MDR.

THE ATTENDING NURSE REPORTED DURING A CORNEAL TRANSPLANT PROCEDURE, THE DONOR CORNEA WAS DAMAGED BY THE TREPHINE BLADE AND THE PROCEDURE HAD TO BE CANCELLED UNTIL THE NEXT DAY. THE TRANSPLANT WAS SUCCESSFULLY COMPLETED, AND THE PT WAS DISCHARGED. BECAUSE THE PROCEDURE WAS POSTPONED, WHICH COULD HAVE CAUSED ADD'L RISK TO THE PT, THE INCIDENT IS BEING FILED AS A MDR.

SEVERAL ATTEMPTS HAVE BEEN MADE BY MEDTRONIC TO CONTACT THE USER FACILITY RISK MGR TO INQUIRE ABOUT THE PT INFO. IF ADD'L INFO IS OBTAINED A F/U REPORT WILL THEN BE FILED. THE CUSTOMER HAD PREPARED THREE DIFFERENT CORNEAL TREPHINE BLADES FOR THE PROCEDURE. WHILE ONLY ONE BLADE CAUSED DAMAGE TO THE DONOR CORNEA, THE CUSTOMER WAS UNSURE WHICH TREPHINE BLADE WAS USED. TWO OTHER SEPARATE MDRS (1045254-2010-00006 / 1045254-2010-00007) WILL BE FILED FOR EACH TREPHINE BLADE. THE FACILITY RISK MGR WAS CONTACTED ABOUT THE RETURN OF THE PRODUCT AND SHE STATED THAT THEY WILL NOT BE RETURNING THE PRODUCT TO MEDTRONIC UNTIL THE FACILITY HAS COMPLETED THEIR INTERNAL INVESTIGATION OF THE EVENT.

SEVERAL ATTEMPTS HAVE BEEN MADE BY MEDTRONIC TO CONTACT THE RISK MGR TO INQUIRE ABOUT THE PT INFO. IF ADD'L INFO IS OBTAINED, A F/U REPORT WILL THEN BE FILED. THE CUSTOMER HAD PREPARED THREE DIFFERENT TREPHINE BLADES FOR THE PROCEDURE. ONLY ONE BLADE HAD CAUSED THE DAMAGE, BUT THE CUSTOMER WAS UNSURE WHICH TREPHINE BLADE WAS USED ON THE DONOR CORNEA. TWO SEPARATE MDRS (1045254-2010-00005 / 1045254-2010-00007) WILL BE COMPLETED FOR EACH OF THE REMAINING ITEMS. THE FACILITY RISK MGR WAS CONTACTED ABOUT THE RETURN OF THE PRODUCT. SHE STATED, SHE WILL NOT BE RETURNING THE PRODUCT UNTIL THE FACILITY HAS COMPLETED THEIR INVESTIGATION.

THE ATTENDING NURSE REPORTED DURING A CORNEAL TRANSPLANT PROCEDURE, THE DONOR CORNEA WAS DAMAGED BY THE TREPHINE BLADE AND THE PROCEDURE HAD TO BE CANCELLED UNTIL THE NEXT DAY. THE TRANSPLANT WAS SUCCESSFULLY COMPLETED AND THE PT WAS DISCHARGED. BECAUSE THE PROCEDURE WAS POSTPONED, WHICH COULD HAVE CAUSED ADD'L RISK TO THE PT, THE INCIDENT IS BEING FILED AS A MDR.