BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3973262 · Received June 6, 2014

    Report

    Report Number
    9612501-2014-00175
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). DATE OF INITIAL REPORT SENT ON: (B)(4) 2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE ENDOSTITCH IS STICKING WHEN THE SURGEON IS TRYING TO TOGGLE THE NEEDLE. THERE WAS A DELAY OVER 30 MINUTES. THIS DELAY IN SURGERY DID NOT AFFECT THE PT IN ANY WAY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500C. NO DEVICE FRAGMENT FELL IN THE PT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331663 ENDO STITCH 10MM SUTURING DEVICE SUTURING DEVICE KOG COVIDIEN J4A1673X

    Patients

    Seq Age Sex Outcome Treatment
    1