BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ENDOSCOPE

    MDR report key: 97442 · Received June 11, 1997

    Report

    Report Number
    2429304-1997-00017
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    May 5, 1997
    Report Date
    June 5, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    HEZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/5/97, DURING THE CORONARY ARTERY BYPASS GRAFT FOR ENDOSCOPIC VEIN HARVESTING, A STAFF MEMBER WENT INTO THE PROCEDURE ROOM TO ANNOUNCE TO THE STAFF THAT THE ENDOSCOPE AND CAMERA BEING USED FOR THE PROCEDURE WERE NOT STERILE. THIS OCCURRED APPROX 20 MINUTES AFTER THE PROCEDURE HAD BEGUN. THE PROCEDURE WAS COMPLETED WITH A SECOND SCOPE AND AS A PRECAUTION AGAINST INFECTION, THE SURGEON DECIDED TO ADMINISTER ANTIBIOTICS LONGER THAN THE 48 HOURS USUALLY RECOMMENDED FOR THIS TYPE OF PROCEDURE. ON 5/23/97, THE SURGEON REPORTED THAT AS A RESULT OF THE EVENT DESCRIBED ABOVE, THE PT DEVELOPED MULTI-ORGAN FAILURE AND SEPSIS. AS A RESULT OF THIS CONDITION, A TRACHEOTOMY AND RENAL DIALYSIS HAVE BEEN PERFORMED AND THE PT IS IN A PARTIAL COMA. HE/SHE IS IN A "NO CODE" ROOM AND WILL NOT BE RESUSCITATED IF TOTAL FAILURE OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPE UNK HEZ THE OLYMPUS OPTICAL CO. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L