BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CLIP APPLIER

    MDR report key: 1022744 · Received January 3, 2007

    Report

    Report Number
    1320894-2007-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    October 26, 2006
    Report Date
    December 4, 2006
    Manufacturer
    CONMED CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN I RECEIVE THE QUALITY ENGINEER'S INVESTIGATION REPORT ON THE DEVICE, I WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS FAILED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC CLIP APPLIER ENDOSCOPIC CLIP APPLER GDO CONMED CORPORATION NA 0603311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN