BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE ENDOSTITCH

    MDR report key: 1328639 · Received February 20, 2009

    Report

    Report Number
    1328639
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 20, 2009
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE LAPAROSCOPIC TROCAR WAS INSERTED INTO THIS INCISION INTO THE ABDOMINAL CAVITY AND AGAIN THE GAS SOURCE, LIGHT SOURCE, AND CAMERA WERE THEN CONNECTED. THERE WAS NO APPARENT INJURY TO THE BOWEL UPON INSERTING THE TROCAR. THE DEFECT THAT WAS NOTED AT THE VAGINAL CUFF WAS CLOSED WITH 2 FIGURE-OF-EIGHT SUTURES USING THE ETHICON ENDO-STITCH. IN THE PROCESS OF USING THE ENDO-STITCH, THERE WAS A SMALL TEENY FRAGMENT OF THE NEEDLE THAT WAS LOST, WAS FOUND. AN ATTEMPT WAS MADE TO REMOVE IT AND AFTER PICKING IT UP WITH THE PICKUP FORCEPS, BETWEEN PICKING IT UP AND GETTING IT OUT OF THE ABDOMEN, THE SMALL TIP OF THIS NEEDLE WHICH WAS PROBABLY LESS THAN ONE TENTH OF A CENTIMETER LONG, MAYBE LESS THAN A SIXTEENTH OF A CENTIMETER LONG WAS NOT FOUND AND SO AN X-RAY WAS DONE INTRAOPERATIVELY AND THERE WAS NO EVIDENCE OF NEEDLE TIP NOTED IN THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDOSTITCH SUTURING DEVICE, ENDOSCOPIC MFJ COVIDIEN UNITED STATES SURGICAL CORPORATION * N8B127

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR NO OTHER THERAPIES| NO OTHER THERAPIES