BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 593252 · Received April 11, 2005

    Report

    Report Number
    593252
    Event Type
    Malfunction
    Date Received
    April 11, 2005
    Date of Event
    February 24, 2005
    Report Date
    April 11, 2005
    Manufacturer
    SRI/SURGICAL EXPRESS, INC.
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN IRRIGATING BIPOLAR CORD FROM THE HARVEST SET WOULD NOT PLUG INTO THE UNIT. THE CORD PLUG JUST KEPT FALLING OUT OF THE HOLES, DESPITE BEING INSERTED ALL THE WAY. ANOTHER CORD WAS ADDED. IT FIT INTO THE SOCKET, BUT NOT TIGHTLY. THE FIT WAS ADEQUATE TO HOLD THE PLUGS IN PLACE WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IRRIGATING BIPOLAR CORD FFZ SRI/SURGICAL EXPRESS, INC. ET0858F NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR