BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE ENDO STITCH 10MM

    MDR report key: 1242034 · Received November 20, 2008

    Report

    Report Number
    1242034
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 20, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING BARIATRIC CASE, UNABLE TO PASS SUTURE FROM ONE SIDE TO THE OTHER WHEN USING AN ENDO STITCH. ENDO STITCH INSTRUMENT WAS PASSED OFF AND A NEW ONE OPENED WITH NO ISSUES. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO STITCH 10MM ENDOSCOPIC SUTURING DEVICE MFJ COVIDIEN UNITED STATES SURGICAL CORPORATION 173016 N8C221

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR