BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDO

    MDR report key: 906874 · Received August 31, 2007

    Report

    Report Number
    1527736-2007-05846
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    June 20, 2007
    Report Date
    July 2, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, EJECTED TWO CLIPS, MALFORMED TWO CLIPS DUE TO AN ANTI-BACKUP FAILURE; THE REMAINING ELEVEN CLIPS WERE FED AND FORMED PROPERLY. HOWEVER, NO ABNORMAL NOISES AND NO JAMMING ISSUES WERE NOTED DURING ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY PROCEDURE, THERE WAS A GRINDING NOISE AND THE CLIPS OCCASIONALLY JAMMED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDO GDO ETHICON ENDO-SURGERY, INC. AN D4GU8J

    Patients

    Seq Age Sex Outcome Treatment
    1 YR