BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MORCELLATOR LAPSAC

    MDR report key: 34534 · Received July 9, 1996

    Report

    Report Number
    34534
    Event Type
    Injury
    Date Received
    July 9, 1996
    Date of Event
    July 3, 1996
    Report Date
    July 5, 1996
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FZT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING PRODUCT DURING LAPROSCOPIC SPLENECTOMY, A HOLE WAS MADE IN DEVICE AND SMALL BOWEL WAS INJURED. THIS NECESSITATED A LAPAROTOMY AND A SMALL BOWEL RESECTION WITH REANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MORCELLATOR LAPSAC SIZE 8" X 5" SURGICAL TISSUE POUCH FZT COOK UROLOGICAL, INC. 054100 226165

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Hospitalization| R