BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELC

    MDR report key: 943418 · Received November 12, 2007

    Report

    Report Number
    1320894-2007-00152
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    September 1, 2004
    Report Date
    November 12, 2007
    Manufacturer
    CONMED CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE REVIEWING FOREIGN VIGILANCE SYSTEM REPORTS, I DISCOVERED THAT THE MEDWATCH REPORT HAD NOT BEEN FILED FOR THIS EVENT. NO DEVICE WAS RETURNED FOR EVAL. THE COMPLAINT HISTORY DATABASE WAS SEARCHED AT THE TIME OF THE REPORT AND NO OTHER COMPLAINT OF ANY TIME HAD BEEN RECEIVED FOR THIS LOT CODE OF THIS DEVICE. IT WAS REPORTED BY THE DISTRIBUTOR THAT THIS HOSPITAL HAD JUST BEEN CONVERTED TO THE CONMED DEVICE AFTER HAVING BEEN USED TO USING THE J&J DEVICE. THIS MAY ACCOUNT FOR THE DROPPING OF THE CLIP, AS THERE ARE DIFFERENCES IN THE MECHANICS OF THE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOSPITAL LINE, A DISTRIBUTOR, THAT, "DURING A SURGICAL PROCEDURE, A CLIP WAS DROPPED IN THE SURGICAL SITE. THE PT STATUS WAS REPORTED AS BEING "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELC ENDOSCOPIC CLIP APPLIER GDO CONMED CORPORATION NA 0406082

    Patients

    Seq Age Sex Outcome Treatment
    1 YR