CORNEAL TREPHINE BLADE 7.5MM
Received Feb 25, 2010 · Event occurred Jan 25, 2010
Report 1045254-2010-00005 · MDR key 1617429
Device
Generic name
86 Hrh
Manufacturer
Medtronic Xomed, Inc.Model number
0009711Catalog number
0009711
Lot number
64473300
Product problems
- Failure to Cut
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
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.