BEUDAMED
    FDA Adverse Event Death Summary report: N

    SABO SAG SAW

    MDR report key: 1735795 · Received June 16, 2010

    Report

    Report Number
    1811755-2010-00660
    Event Type
    Death
    Date Received
    June 16, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS INCIDENT WAS REQUESTED ON 06/02/10, 06/09/10, AND 06/15/10 FROM THE ACCOUNT AND AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN PROVIDED. ON 06/02/10, 06/09/10 AND 06/14/10, THE MANUFACTURER REQUESTED THE DEVICE FROM THE ACCOUNT, AND AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. ACCORDING TO INFORMATION PROVIDED BY THE RISK MANAGER AT THE ACCOUNT, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED AND THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACCOUNT THAT WHILE THE SURGEON WAS USING THE STRYKER SABO SAW TO PERFORM A REVISION OPEN HEART SURGERY, THERE WAS A LACERATION OF ONE OF THE PATIENT'S VENTRICLES. IT WAS ALSO REPORTED THAT THE SURGEON WAS UNABLE TO REPAIR THE LACERATION, AND UNABLE TO PUT THE PATIENT ON BYPASS. THE PATIENT REPORTEDLY DIED AS A RESULT OF THE LACERATION AND THE INABILITY TO BE PLACED ON BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABO SAG SAW INSTRUMENT,SURGICAL,ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK