BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 470119 · Received June 24, 2003

    Report

    Report Number
    9611174-2003-00001
    Event Type
    Injury
    Date Received
    June 24, 2003
    Date of Event
    May 21, 2001
    Report Date
    June 21, 2003
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    EZM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IS A GUIDE WIRE USED DURING ENDOSCOPIC PER-ORAL DILATATION OF TUMORS IN THE ESOPHAGUS. IT HAS A FLEXIBLE COILED SPRING TIP THAT BECAME DETACHED FROM THE MAIN PORTION OF THE WIRE DURING A PROCEDURE. THE PT REQUIRED AN ESOPHAGECTOMY TO REPAIR A 2CM TEAR IN THE LOWER ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ESOPHAGEAL GUIDE WIRE EZM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD. 7028717 110641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention GI ENDOSCOPE & DILATATION DEVICE (MAKE/MODELS UNK)