BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 822811 · Received March 1, 2007

    Report

    Report Number
    8010047-2007-00023
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    November 15, 2006
    Report Date
    February 13, 2007
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THE HOSP HAS BEEN CONTACTED FOR ADD'L INFO REGARDING THE REPORTED EVENT. ACCORDING TO THE RISK MGR, THEY DO NOT SUSPECT THIS GASTROSCOPE AS THE CAUSE OF THE PT'S OUTCOME, SINCE THERE WAS NO REPORTED DEVICE MALFUNCTION. THE ENDOSCOPE WAS RETURNED TO SERVICE AND NO PROBLEMS WERE REPORTED SINCE THEN. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT FLEXIBLE ENDOSCOPY HAD BEEN ATTEMPTED WITH THE SUBJECT DEVICE TO CLEAR AN ESOPHAGEAL FOREIGN BODY. THE USERS WERE REPORTEDLY UNSUCCESSFUL IN THE INITIAL ATTEMPT, AND THE PT WAS TAKEN TO THE OPERATING ROOM, WHERE AN UNSPECIFIED MODEL OF RIGID SCOPE WAS USED TO ATTEMPT CLEARANCE OF THE FOREIGN BODY. DURING THIS PROCEDURE, AN UNSPECIFIED AMOUNT OF BLEEDING WAS REPORTEDLY OBSERVED. THE RIGID SCOPE WAS REMOVED, AND AN UNSPECIFIED MODEL OF FLEXIBLE ENDOSCOPE THEN DEPLOYED, AND A PERFORATION WAS SUBSEQUENTLY FOUND IN THE PT'S ESOPHAGUS. THE FOREIGN BODY WAS SUCCESSFULLY ADVANCED INTO THE STOMACH, AND THE PT LATER DEVELOPED A "SIGNIFICANT AMOUNT" OF SUBCUTANEOUS EMPHYSEMA IN THE FACE, NECK, AND CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE GCK OLYMPUS OPTICAL CO. LTD. GIF-O180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention