BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELC CLIP APPLIER

    MDR report key: 730515 · Received June 22, 2006

    Report

    Report Number
    1320894-2006-00043
    Event Type
    Malfunction
    Date Received
    June 22, 2006
    Date of Event
    May 1, 2006
    Report Date
    June 22, 2006
    Manufacturer
    CONMED CORP.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING DECONTAMINATED. AS SOON AS THE ENGINEER CAN EVALUATED THE DEVICE AND WRITE HIS REPORT. I WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY JSS, ( A JAPANESE DISTRIBUTOR) THAT "DURING A SURGICAL PROCEDURE, CLIPS FELL OUT OF THE JAWS OF THE CLIP APPLIER, INTO THE SURGICAL SITE. THE CLIPS WERE RETRIEVED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS NOT ALTERED AND THE SURGERY TIME WA NOT EXTENDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELC CLIP APPLIER ENDOSCOPIC CLIP APPLIER FZP CONMED CORP. NA 0511013

    Patients

    Seq Age Sex Outcome Treatment
    1