TREPHINE BLADE, 9.25MM, STERILE, 1/EA

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING INVESTIGATION CONCLUSIONS.

Description of Event or Problem

THE COMPLAINT DESCRIBES AN INCIDENT INVOLVING A 9.25 MM TREPHINE USED DURING A CORNEAL TRANSPLANT PROCEDURE (PENETRATING KERATOPLASTY, PK). DURING THE SURGERY, THE SURGEON ATTEMPTED TO TREPHINE THE DONOR TISSUE; HOWEVER, THE DEVICE DID NOT FULLY CUT THROUGH AS INTENDED. AS A RESULT, THE SURGEON ATTEMPTED TO MANUALLY COMPLETE THE PROCEDURE, WHICH LED TO DAMAGE OF THE DONOR CORNEAL TISSUE. THE CUSTOMER INDICATED A POTENTIAL ISSUE WITH THE DEVICE ASSEMBLY, SPECIFICALLY A GAP BETWEEN THE TREPHINE BLADE AND HANDLE, WHICH MAY HAVE CONTRIBUTED TO THE MALFUNCTION. AT THE TIME OF THE INCIDENT, THE PATIENT'S NATIVE CORNEA HAD ALREADY BEEN REMOVED, LEAVING THE EYE OPEN AND PREPARED FOR IMPLANTATION OF THE DONOR TISSUE. DUE TO THE DAMAGE TO THE INITIAL DONOR TISSUE, A REPLACEMENT GRAFT HAD TO BE URGENTLY OBTAINED FROM THE EYE BANK. THIS RESULTED IN A DELAY OF THE SURGICAL PROCEDURE WHILE THE PATIENT REMAINED UNDER GENERAL ANESTHESIA, WITH THE SURGICAL TEAM AWAITING THE NEW TISSUE. IT WAS NOTED THAT THE RESIDENT HAD TO RETRIEVE THE REPLACEMENT TISSUE IN REAL TIME. FORTUNATELY, A SUITABLE REPLACEMENT WAS AVAILABLE, AND THE PROCEDURE WAS ABLE TO CONTINUE. THE REPORTED COMPLICATION ASSOCIATED WITH THIS EVENT WAS DAMAGE TO THE DONOR TISSUE, NECESSITATING REPLACEMENT. AT THIS TIME, NO INFORMATION HAS BEEN PROVIDED REGARDING THE PATIENT'S CURRENT CONDITION OR WHETHER ANY ADDITIONAL CLINICAL COMPLICATIONS OR INTERVENTIONS WERE REQUIRED AS A RESULT OF THE DELAY. BASED ON THE AVAILABLE INFORMATION, THIS EVENT INVOLVES A DEVICE MALFUNCTION (INCOMPLETE CUTTING PERFORMANCE OF THE TREPHINE, POTENTIALLY RELATED TO IMPROPER FIT BETWEEN THE BLADE AND HANDLE) THAT OCCURRED DURING SURGERY. THE MALFUNCTION CONTRIBUTED TO DAMAGE OF THE DONOR TISSUE AND RESULTED IN A PROCEDURAL DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA WITH AN OPEN EYE. SUCH CIRCUMSTANCES REPRESENT A SITUATION THAT COULD LEAD TO SERIOUS DETERIORATION IN THE PATIENT'S CONDITION IF IT WERE TO RECUR.