BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEZHAT DORSEY TUBE SET

    MDR report key: 578542 · Received February 17, 2005

    Report

    Report Number
    1213643-2005-00022
    Event Type
    Malfunction
    Date Received
    February 17, 2005
    Date of Event
    January 18, 2005
    Report Date
    January 18, 2005
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUCTION BUTTON STUCK IN OPEN POSITION ONE HOUR INTO TOTAL HEYSTRECTOMY. LOSS OF PNEUMO. NO ROBOTOCS. FOUR PREVIOUS INCIDENTS NOT REPORTED. CUSTOMER DECLINED TO ANSWER ANY FURTHER QUESTIONS. NO SMOKEVAC INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEZHAT DORSEY TUBE SET LAPAROSCOPIC TUBE SET GGJ DAVOL INC., SUB. C.R. BARD, INC. * 41KON011

    Patients

    Seq Age Sex Outcome Treatment
    1 *