BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 1900986 · Received November 11, 2010

    Report

    Report Number
    MW5018196
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON, THE ENDOCLIP 10MM APPLIER WAS NOT FUNCTIONING CORRECTLY DURING THE LAP CHOLE PROCEDURE. DEVICE AND CLIPS REMOVED FROM FIELD. NO ADVERSE EFFECT TO PT. DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDOCLIP L 10MM GDO COVIDIEN SURGICAL DEVICES REF 176625 N0G0692

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR