BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAPSAC

    MDR report key: 2920584 · Received January 5, 2007

    Report

    Report Number
    1825146-2006-00029
    Event Type
    Death
    Date Received
    January 5, 2007
    Date of Event
    October 27, 2006
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    KGY
    PMA / PMN Number
    K910914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVAL CANNOT BE PERFORMED AT THIS TIME, DUE TO THE PRODUCT NOT BEING RETURNED. CURRENTLY WORKING THROUGH THE ATTORNEY TO DETERMINE A DATE TO VIEW THE PRODUCT AT THE HOSPITAL. AT THE PRESENT TIME, THERE HAS NOT BEEN AN INDICATION OF THE FAILURE MODE AND NOTHING STATING WHICH IF EITHER DEVICE FAILED. PRODUCTS FROM INTERNAL STOCK WAS PULLED AND EVALUATED ENSURING SEALS ARE INTACT NOTING THE PRODUCTS TO BE WITHIN SPECIFICATION. NOTHING WAS VIEWED THAT COULD HAVE POTENTIALLY CAUSED THIS TYPE OF INCIDENT. AS INFO BECOMES AVAILABLE, IT WILL BE PROMPTLY FORWARDED.

    Description of Event or Problem · 1

    "ON (B)(6) 2006, A PT WAS INJURED DURING A LAPAROSCOPIC SPLENECTOMY. TWO DEVICES WERE UTILIZED DURING THE COURSE OF THE SURGERY; NAMELY, A GYNECARE X-TRACT TISSUE MORCELLATOR AND A COOK UROLOGICAL, INC. LAPSAC SURGICAL TISSUE POUCH. IT WOULD APPEAR FROM OUR PRELIMINARY INVESTIGATION THAT THE TISSUE MORCELLATOR PENETRATED THE BAG AND INJURED THIS PT'S AORTA, VENA CAVA AND BOWEL. SPECIFICALLY, THE COOK BAG USED DURING THE SURGERY WAS THE 8X10 POUCH, ORDER NO.(B)(4), LOT. NO. U1551052."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPSAC SURGICAL TISSUE POUCH KGY COOK UROLOGICAL, INC. U1551052

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death