BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONEPORT SURGICAL TROCAR

    MDR report key: 1203670 · Received October 9, 2008

    Report

    Report Number
    1317214-2008-00141
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 6, 2008
    Manufacturer
    CONMED CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS BEING RETURNED FROM ANOTHER COUNTRY, FOR EVAL. WHEN THE DEVICE HAS BEEN EVALUATED BY THE QUALITY ENGINEER, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR, VITALITEC, THE SURGEON REPORTED THAT, "THE SHIELDS ON THE TROCAR DEPLOYED SLOWLY." THERE WAS NO PT INJURY OR EXTENSION OF THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONEPORT SURGICAL TROCAR SURGICAL TROCAR GCJ CONMED CORP. NA 0804161

    Patients

    Seq Age Sex Outcome Treatment
    1