BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EHD STERNUM SAW

    MDR report key: 1542787 · Received November 13, 2009

    Report

    Report Number
    1811755-2009-00770
    Event Type
    Injury
    Date Received
    November 13, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 14, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DWH
    PMA / PMN Number
    K863447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. ACCORDING TO THE INFORMATION RECEIVED FROM THE RISK MANAGEMENT DEPARTMENT AT THE ACCOUNT, THE HANDPIECE WILL NOT BE RETURNED UNTIL AN INTERNAL INVESTIGATION IS COMPLETE. IF THE DEVICE IS RETURNED TO THE MANUFACTURER, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT, OIL LEAKED FROM THE TOP OF THE HANDPIECE INTO THE CHEST CAVITY. THE SITE WAS IMMEDIATELY IRRIGATED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE STATUS OF THE PATIENT, DESPITE NUMEROUS ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EHD STERNUM SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT DWH STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention