BEUDAMED
    FDA Adverse Event Other Summary report: N

    M2 MICROKERATOME BLADE

    MDR report key: 1047435 · Received May 16, 2008

    Report

    Report Number
    2529598-2008-00002
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    September 22, 2005
    Report Date
    May 9, 2008
    Manufacturer
    MORIA, S.A., C.E.
    Product Code
    HMY
    PMA / PMN Number
    K002191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF ITS STANDARD MFG PROCESS, MORIA CONDUCTS MULTIPLE QUAL CHECKS IN (B) (4) (WHERE ITS PROD ARE MFR) AND IN (B) (4) (WHERE PRODUCTS ARE PACKAGED AND DISTRIBUTED) BEFORE SHIPPING ITS PRODUCTS TO CUSTOMERS. THE DAMAGE AND CORROSION TO THE BLADE IN THIS CASE IS NOT OF THE TYPE THAT OCCURS DURING THE MFG PROCESS AND EVEN IF IT WERE, IT WOULD HAVE BEEN CAUGHT BY THE COMPANY'S QUAL CONTROL PROCESS. MORIA ALSO HAS NO RECORD OF ANY PROBLEMS OR CUSTOMER COMPLAINTS WITH RESPECT TO OTHER BLADES FROM THE LOT FROM WHICH THE BLADE AND QUESTION WAS PRODUCED. FURTHERMORE, MORIA SHIPS ITS BLADES IN SPECIAL BLISTER PACKAGING THAT IS DESIGNED TO PROTECT THE BLADES FROM DAMAGE DURING THE SHIPPING PROCESS. WHEN THE BLADE WAS RETURNED FOR INSPECTION, IT WAS NOT IN ITS ORIGINAL BLISTER PACKAGING. DAMAGE TO THE BLADE COULD HAVE OCCURRED AT ANY POINT AFTER IT WAS REMOVED FROM MORIA'S PACKAGING, SUCH AS WHEN IT WAS SHIPPED TO MORIA FOR INSPECTION. DAMAGE TO THE BLADE COULD ALSO HAVE OCCURRED DURING HANDLING AND USE IF PROPER PRECAUTIONS WERE NOT TAKEN. THE M2 INSTRUCTION MANUAL CONTAINS CLEAR WARNINGS THAT THE BLADE CAN BE DAMAGED DURING INSERTION TO THE METAL HEAD, AND RECOMMENDS CHECKING THE BLADE BEFORE AND AFTER INSERTION. ALSO, THE CUSTOMER SHOULD "[A]VOID INADVERTENT CONTACT WITH THE SUCTION RING PIVOT POST AND M2 HEAD BLADE AEA." THE MANUAL FURTHER WARNS THAT "IF CONTACT OCCURS, BLADE EDGE MAY BECOME DAMAGED AND A NEW BLADE SHOULD BE USED." REGARDLESS OF WHEN THE DAMAGE TO THE BLADE OCCURRED, IT DID NOT CONTRIBUTE TO THE TEAR. BECAUSE OF THE OSCILLATING NATURE OF THE MICROKERATOME, THE DAMAGE TO THE BLADE COULD NOT HAVE CAUSED THE CLEAN CUT OF THE FLAP THAT OCCURRED IN THIS CASE. CONCERNING THE MOTOR, (B) (6) BOUGHT THE M2 MOTOR FROM MORIA IN JULY, 2004, AND THE MOTOR WAS LAST SERVICED AND RETURNED TO (B) (6) ON (B) (6) 2005. WHEN THE MOTOR WAS SHIPPED BACK TO MORIA ON SEPT. 30, 2005, THE INSPECTION FOUND VISIBLE OXIDATION AND DEBRIS THAT AFFECTED THE TORQUE (POWER) OF THE MOTOR THAT PRODUCES THE OSCILLATING MOTION OF THE BLADE. THIS OXIDATION AND DEBRIS WOULD NOT HAVE BEEN ON THE MOTOR WHEN IT WAS SHIPPED BACK TO (B) (6) ON JULY 23, 2005, BUT OXIDATION AND DEBRIS CAN BUILD UP ON THE MOTOR IN A RELATIVELY SHORT PERIOD OF TIME IF THE MAINTENANCE INSTRUCTIONS ARE NOT CAREFULLY FOLLOWED. THE M2 INSTRUCTION MANUAL CONTAINS CLEAR INSTRUCTIONS AND WARNINGS ABOUT MAINTAINING THE MOTOR. FOR EXAMPLE, THE MANUAL STATES THAT "[T]HE HEAD, ELECTRIC MOTOR, AND SUCTION RINGS MUST BE CAREFULLY CLEANED AFTER EACH SURGICAL PROCEDURE," AND STATES IN ALL CAPS THAT "ALL MICROKERTOME PARTS MUST BE CLEANED, DISINFECTED, STERILIZED, AND DRIED AFTER EACH SURGICAL PROCEDURE." SUCH OXIDATION AND DEBRIS LIKE THE TYPE THAT WAS FOUND DURING THE INSPECTION CAN AFFECT THE PERFORMANCE OF THE MOTOR BY REDUCING THE AMOUNT OF TORQUE IT PRODUCES AND THEREFORE SLOWING DOWN THE OSCILLATION OF THE BLADE. THIS COULD HAVE CONTRIBUTED TO THE TYPE OF DEFECT REPORTED, ALTHOUGH MORIA DOES NOT KNOW FOR CERTAIN. THERE ARE NUMEROUS OTHER POSSIBLE CAUSES OF A TORN FLAP DURING LASIK, INCLUDING BUT NOT LIMITED TO LOSS OF SUCTION AND MOVEMENT BY THE PT. MORIA DOES NOT HAVE SUFFICIENT INFO TO DETERMINE WHETHER THE PT SUSTAINED A "SERIOUS INJURY" WITHIN THE MEANING OF THAT TERM UNDER THE FDA RULES BECAUSE WE HAVE NOT RECEIVED THE PT'S CURRENT MEDICAL RECORDS. THEREFORE, MORIA HAS NOT BEEN ABLE TO CONCLUDE WHETHER THIS IS A REPORTABLE EVENT. MORIA HAS LEARNED THAT THE PT HAS FILED A LAWSUIT AGAINST THE TREATING SURGEON AND FACILITY ALLEGING THAT AS A RESULT OF THE SURGERY, HER RIGHT EYE SUSTAINED CORNEAL SCARRING AND THAT SHE NOW SUFFERS FROM POOR VISION AND "GHOST VISION." MORIA IS NOT A PARTY TO THIS SUIT, BUT HAS ASKED THE PT'S ATTORNEY FOR A COPY OF THE PT'S CURRENT MEDICAL RECORDS. WE HAVE NOT RECEIVED THE MEDICAL RECORDS. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, WE ARE REPORTING THIS EVENT NOW RATHER THAN CONTINUE TO WAIT FOR THE MEDICAL RECORDS.

    Description of Event or Problem · 1

    (B) (6) UNDERWENT LASIK SURGERY ON HER RIGHT EYE ON (B) (6) 2005. MORIA'S M2 MICROKERATOME AND BLADE WERE USED IN THE PROCEDURE. THE SURGERY RESULTED IN AN IRREGULAR TORN CORNEAL FLAP. THIS IS AN INFREQUENT, BUT KNOWN COMPLICATION OF THE SURGERY. (B) (6), THE FACILITY AT WHICH THE SURGERY WAS PERFORMED, REPORTED THE INCIDENT TO MORIA THE DAY OF THE SURGERY AND ON (B) (6) 2005 RETURNED THE MICROKERATOME MOTOR AND BLADE THAT WERE USED IN THE PROCEDURE. MORIA'S EXAMINATION FOUND THAT THERE WAS AN ACCUMULATION OF SURGICAL DEBRIS ON THE M2 MOTOR AND OXIDATION ON THE BLADE OSCILLATION SHAFT. THE INSPECTION ALSO FOUND THAT THE BLADE'S EDGE WAS NICKED AND CORRODED. THIS DAMAGE AND CORROSION TO THE BLADE COULD ONLY HAVE OCCURRED DURING HANDLING OR USE AFTER THE BLADE WAS SHIPPED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2 MICROKERATOME BLADE KERATOME BLADE (HMY) HMY MORIA, S.A., C.E. 19329 449513

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other VIGAMOX/ZYMAR DROPS| NAPHCON A DROPS| VALIUM