BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1530333 · Received November 9, 2009

    Report

    Report Number
    1530333
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    September 30, 2009
    Report Date
    November 7, 2009
    Manufacturer
    NA
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SETTING UP THE STERILE FIELD, THE SCRUB NURSE FELT THAT SOME LAP SPONGES WERE MOIST. SHE PASSED ONE OFF THE FIELD FOR EVALUATION FROM OTHER SURGICAL TEAM MEMBERS WHO CONCURRED. CHARGE NURSE AND THORACIC SERVICE LEAD WERE NOTIFIED AND CAME TO THE ROOM TO HELP. THE STERILE FIELD WAS BROKEN DOWN AND REPLACED. ANOTHER PULMONARY PACK WAS OPENED AND WAS TAKEN DOWN FOR THE SAME REASON ( MOIST LAP). IN ADDITION, A GOWN PACK WAS ALSO COLD AND MOIST AND HAD TO BE REPLACED. FINALLY, WE OPENED SUPPLIES INDIVIDUALLY ON A NEW STERILE FIELD & PROCEEDED WITH PROCEDURE.

    Description of Event or Problem · 1

    WHILE SETTING UP THE STERILE FIELD, THE SCRUB NURSE FELT THAT SOME LAP SPONGES WERE MOIST. SHE PASSED ONE OFF THE FIELD FOR EVALUATION FROM OTHER SURGICAL TEAM MEMBERS WHO CONCURRED. CHARGE NURSE AND THORACIC SERVICE LEAD WERE NOTIFIED AND CAME TO THE ROOM TO HELP. THE STERILE FIELD WAS BROKEN DOWN AND REPLACED. ANOTHER PULMONARY PACK WAS OPENED AND WAS TAKEN DOWN FOR THE SAME REASON ( MOIST LAP). IN ADDITION, A GOWN PACK WAS ALSO COLD AND MOIST AND HAD TO BE REPLACED. FINALLY, WE OPENED SUPPLIES INDIVIDUALLY ON A NEW STERILE FIELD & PROCEEDED WITH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SPONGE, LAPAROSCOPIC GDY NA * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR