BEUDAMED
    FDA Adverse Event Other Summary report: N

    12MM DURAGOLD RADIOLUCENT REUSABLE CANNULA

    MDR report key: 217495 · Received April 5, 1999

    Report

    Report Number
    217495
    Event Type
    Other
    Date Received
    April 5, 1999
    Date of Event
    February 10, 1999
    Report Date
    February 12, 1999
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO EXTRACT A STONE THROUGH CANNULA, THE CANNULA CRACKED AND SMALL PIECES BROKE OFF INSIDE THE ABDOMINAL CAVITY. A SEARCH WAS MADE AND 3 SMALL PIECES OF THE CANNULA WERE RETRIEVED. THE RETRIVED PIECES OF THE CANNULA WERE SENT TO PATHOLOGY. THE CANNULA WAS RETAINED FOR INVESTIGATION BY THE MFR. PT RECOVERED FROM SURGERY AND WAS DISCHARGED. NO LONG TERM EFFECT IS APPARENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM DURAGOLD RADIOLUCENT REUSABLE CANNULA CANNULA GEA APPLIED MEDICAL RESOURCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other