BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEZHAT-DORSEY TIM SMOKEEVAC TM TRUMPET VALVE

    MDR report key: 228752 · Received June 22, 1999

    Report

    Report Number
    228752
    Event Type
    Malfunction
    Date Received
    June 22, 1999
    Date of Event
    June 18, 1999
    Report Date
    June 21, 1999
    Manufacturer
    DAVOL INC. SUBSIDIARY OF CR BARD, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A GYNECOLOGIC LAPAROSCOPIC SURGERY, DEVICE WAS USED AS IRRIGATOR/SMOKE EVACUATOR. HOWEVER, WHEN NOT IN USE, THE DEVICE CONTINUED TO "SUCTION." DURING PERIOD OF NON-USE DEVICE WAS RESTING ON BOWEL, THE SUCTION THEN CREATED A LARGE HEMATOMA ON THE BOWEL. LAPAROSCOPIC FILM SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEZHAT-DORSEY TIM SMOKEEVAC TM TRUMPET VALVE IRRIGATOR/SMOKE EVACUATOR FCZ DAVOL INC. SUBSIDIARY OF CR BARD, INC. * 41DJN015

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other