BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIEMER LDV FEMTOSECOND LASER

    MDR report key: 2176773 · Received June 10, 2011

    Report

    Report Number
    3004858034-2011-00001
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    June 9, 2011
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    GEX
    PMA / PMN Number
    K053511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: OUR SUPPLIER DID REVIEW THEIR SOP WHICH SHOWED THAT EVERYTHING IS CORRECT. ALSO THE BATCH RECORD DID NOT SHOW ANY NON-CONFORMITY. IN ADDITION THE REVIEW OF ALL BATCH RECORDS SHOWED THAT THE MISUSE OF THE ARTICULATING ARM WAS A SINGLE EVENT. ACCORDING TO OUR EXPERIENCE MULTIPLE FACTORS ARE RESPONSIBLE FOR A SUCCESSFUL SURGERY. OUR INVESTIGATION ABOUT THE MISSING PART CLEARLY SHOWED THAT THE PATIENT WAS NEVER EXPOSED TO ANY RISK OF DEATH OR SERIOUS INJURY. HOWEVER WE CAN NOT FULLY EXCLUDE THAT THE ASSEMBLING ERROR MIGHT HAVE AFFECTED THE CUTTING PERFORMANCE. CONCLUSIONS: AFTER ANALYSIS OF THE FULL CASE WE CAN CONCLUDE. THE SOP OF THE SUPPLIER IS CORRECT. USING THE ARTICULATING ARM FOR TRAINING, CONTRARY TO THE FLOW OF MATERIAL DEFINED IN THE SOP COULD BE ISOLATED TO A SINGLE EVENT BASED ON HUMAN ERROR WITHOUT ANY INFLUENCE ON ALL INSTALLED DEVICES. WE CONFIRM CORRECT AND APPROPRIATE MEASURES OF THE SURGEON GUARANTEED A SAFE TREATMENT OF THE PATIENT. ACTIONS TAKEN: EVEN THOUGH THE SOP WERE ANALYZED AS CORRECT THE SUPPLIER IMPLEMENTED ADDITIONAL IPC (IN PROCESS CONTROL) AND FQC (FINAL QUALITY CHECK) CONTROLS. ALL AFFECTED MANUFACTURER PERSONNEL WERE TRAINED ABOUT THE STANDARD MATERIAL FLOW AND THE ADDITIONAL IPC AND FQC. ZIEMER DID ADAPT THEIR INCOMING GOODS INSPECTION PROCEDURE.

    Description of Event or Problem · 1

    THE MAUDE EVENT REPORT DELIVERED TO ZIMMER OPHTHALMIC SYSTEMS AG HAS MADE US AWARE OF A SURGICAL INCIDENT. THE SURGEON OBSERVED BUBBLES WHICH WERE TOO ANTERIOR AND THEREFORE DETERMINED NOT TO OPEN THE FLAP. AT THIS TIME ANTIBIOTICS AND STEROID DROPS WERE INSTILLED INTO THE RIGHT EYE AND THE PROCEDURE HAD TO BE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIEMER LDV FEMTOSECOND LASER AC-POWERED KERATOME GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING CLASSIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention