BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELC

    MDR report key: 881542 · Received July 16, 2007

    Report

    Report Number
    1320894-2007-00109
    Event Type
    Malfunction
    Date Received
    July 16, 2007
    Date of Event
    June 11, 2007
    Report Date
    July 16, 2007
    Manufacturer
    CONMED CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. THE QUALITY ENGINEER HAS NOT AT THIS TIME COMPLETED HIS EVALUATION AND INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE REPORT IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING A SURGICAL PROCEDURE THE LOADED CLIPS DROPPED OUT OF THE JAWS. THERE WAS NO PT INJURY REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELC ENDOSCOPIC CLIP APPLIER GDO CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR