BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 685731 · Received March 10, 2006

    Report

    Report Number
    6000123-2006-00021
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    February 11, 2006
    Report Date
    February 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC MIAMI
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN INFECTION GOLD PROBE WAS USED FOR A THERAPEUTIC EFD. DURING THE PROCEDURE, THE TIP BROKE OFF INSIDE OF THE PATIENT. IT SHOULD BE NOTED THAT IT IS THE CAUTERIZING TIP THAT IS EMBEDDED AND NOT THE NEEDLE GUIDE. THERE WAS AN ATTEMPT TO REMOVE THE FRAGMENT WITH A SNARE WHICH WAS UNSUCCESSFUL. THEREFORE, THE PATIENT WAS SCHEDULED FOR SURGERY TO HAVE TIP REMOVED. THERE IS A POSSIBILITY OF ESOPHAGEAL PERFORATION ALTHOUGH THIS INFORMATION COULD NOT BE CONFIRMED. THERE IS NOT FURTHER INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE HEMOSTATIS KNS BOSTON SCIENTIFIC MIAMI * B293940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention