BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 528487 · Received May 11, 2004

    Report

    Report Number
    528487
    Event Type
    Other
    Date Received
    May 11, 2004
    Date of Event
    April 1, 2004
    Report Date
    April 1, 2004
    Manufacturer
    KARL STORZ ENDOSCOPY - AMERICAN, INC.
    Product Code
    HQE
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED TO HAVE A SURGICAL PROCEDURE (PARS PLANA VITRECTOMY WITH CAPSULOTOMY) ON THE RIGHT EYE. IN THE OPERATING ROOM, THE SURGICAL TECHNICIAN PASSED TUBING OFF OF THE STERILE FIELD TO THE CIRCULATOR (RN) IN ORDER TO HAVE THE TUBING CONNECTED TO THE APPROPRIATE PORTS. ACCORDING TO STAFF, IT APPEARS THAT THE VITRECTOMY LINE AND GAS LINE WERE CONNECTED INCORRECTLY TO THE VITRECTOMY MACHINE. THIS INCORRECT PLACEMENT OF LINES CAUSED AN INCREASED PRESSURE IN THE IRRIGATION BOTTLE, AS WELL AS AN INCREASED PRESSURE WITHIN THE OPERATIVE SITE. STAFF INDICATED THAT THE POTENTIAL FOR MAKING SAME MISTAKE COULD HAPPENED AGAIN DESPITE FACT THAT PORT SITES ARE LABELED. (ISSUE HERE IS THE POSITION OF THE MACHINE AT THE FOOT OF THE BED AS THE NURSE DOES NOT HAVE ADEQUATE VISIBILITY OF PORT SITES WHEN CONNECTING TUBING.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VITRECTOMY MACHINE HQE KARL STORZ ENDOSCOPY - AMERICAN, INC. DP 3472 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other