BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CLIP APPLIER

    MDR report key: 876046 · Received September 13, 2006

    Report

    Report Number
    1320894-2006-00070
    Event Type
    Malfunction
    Date Received
    September 13, 2006
    Date of Event
    January 1, 2006
    Report Date
    August 17, 2006
    Manufacturer
    CONMED CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED IN THE PROCEDURE WAS DESTROYED BY THE FACILITY, SO THE DEVICE COULD NOT BE EXAMINED BY OUR QUALITY ENGINEER. THE DHL WAS REVIEWED FOR THIS PRODUCT AND FOUND NO FAILURES FOR THE REPORTED LOT CODE #0603062. WITHOUT THE DEVICE TO EXAMINE, WE ARE UNABLE TO DETERMINE THE REPORTED FAILURE. WE CONSIDER THIS COMPLAINT COMPLETE AND CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "CLIPS DROPPED OUT OF THE DEVICE AND FELL INTO THE PT." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO CONMED CORPORATION NA 0603062

    Patients

    Seq Age Sex Outcome Treatment
    1 YR