BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORIA ONE USE MICROKERATOME

    MDR report key: 1413319 · Received July 4, 2009

    Report

    Report Number
    2529598-2009-00001
    Event Type
    Injury
    Date Received
    July 4, 2009
    Date of Event
    April 6, 2009
    Report Date
    June 3, 2009
    Manufacturer
    MORIA, S.A., C.E.
    Product Code
    HMY
    PMA / PMN Number
    K981742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY RETURNED TO MORIA ITS ONE USE TURBINE AND HOSE FOR EVALUATION, AS WELL TWO USED DISPOSABLE HEADS AND TWO UNOPENED DISPOSABLE HEADS (ALL HEADS WERE FROM LOT 840418). THE PRODUCTS WERE RECEIVED BY MORIA ON 04/15/2009, AND ON 04/16/2009, MORIA SENT A LOANER TURBINE, A NEW HOSE, AND TEN DISPOSABLE HEADS TO THE FACILITY FOR US IN FUTURE SURGERIES. MORIA'S INSPECTION OF THE RETURNED EQUIPMENT REVEALS THAT THERE WAS MODERATE TO HEAVY DEBRIS CAUSED BY OXIDATION IN THE INTERNAL, THREADED COLLAR OF THE TURBINE. PHOTOS ARE ATTACHED AT TAB B. IN ADDITION, THE HOSE WAS IN NEED OF A GENERAL CLEANING. NO PROBLEMS WERE FOUND WITH THE DISPOSABLE HEADS. MORIA RECOMMENDS THAT SUCH TURBINES BE SERVICED ANNUALLY. SEE PART TWO OF THE INSTRUCTION MANUAL, ATTACHED AT TAB C. WHILE IT WAS CLEAR THAT BOTH THE TURBINE AND HOSE WERE IN NEED OF ROUTINE MAINTENANCE, THERE ARE MULTIPLE POSSIBLE CAUSES OF DLK, AND MORIA CANNOT DETERMINE THE ACTUAL CAUSE OF DLK FOR ANY OF THE FIVE PTS WHO EXPERIENCED THE COMPLICATION. MORIA HAS CONCLUDED THAT THE PROBLEM WITH OXIDATION ON THE TURBINE'S THREADED COLLAR, AND WITH FACILITY EXPERIENCE WITH THE PRODUCT, ARE ISOLATED INCIDENTS THAT DO NOT PRESENT QUALITY CONTROL ISSUES. THE FACILITY HAS ONLY HAD ISSUES WITH THE TURBINE/HEAD COMBINATION USED IN THE FIVE INCIDENTS, AND MORIA'S INTERNAL EVALUATION FOUND NO ISSUES WITH TURBINES WITH OTHER SERIAL NUMBERS, WITH UNOPENED DISPOSABLE HEADS FROM THE SAME LOT NUMBER, OR WITH DISPOSABLE HEADS FROM OTHER LOT NUMBERS. FURTHERMORE, THE FACILITY APPARENTLY DID NOT HAVE ANY SUBOPTIMAL OUTCOMES FROM SURGERIES PERFORMED WITH THE LOANER EQUIPMENT IT RECEIVED FROM MORIA ON 04/16/2009. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IN 2009, MORIA RECEIVED NOTICE OF FIVE CASES OF DLK IN PTS WHO HAD BEEN OPERATED ON USING A ONE USE MICROKERATOME. THE TURBINE INVOLVED WITH THE SURGERIES CARRIES A UNIQUE SERIAL NUMBER, AND THE ONE USE HEADS WERE ALL FROM LOT 840418. OF THE FIVE PTS WHO UNDERWENT SURGERY AND SUFFERED COMPLICATIONS, TWO ARE REPORTEDLY "NOT DOING WELL", AND ONE IS NON-FUNCTIONING OUT OF ONE EYE. MORIA WAS NOTIFIED THAT ONE PT WAS NON-FUNCTIONING OUT OF ONE EYE IN 2009. PTS WHOSE SURGERIES INVOLVED OTHER ONE USE TURBINES AND HEADS SUFFERED NO SUCH ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORIA ONE USE MICROKERATOME NONE HMY MORIA, S.A., C.E. 19155 [TURBINE] 840418 [DISP.HEAD]

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other