BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER

    MDR report key: 2024310 · Received March 7, 2011

    Report

    Report Number
    2024310
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    January 31, 2011
    Report Date
    March 7, 2011
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD WAS SUTURING MESH TO THE VAGINAL WALL USING THE ENDOWRIST (A MEGA SUTURECUT NEEDLE DRIVER USED WITH THE DAVINCI ROBOT). THE CIRCULATOR NOTICED THAT A WIRE WAS HANGING FROM THE ENDOWRIST. SURGERY DEPARTMENT OPENED UP ANOTHER ENDOWRIST INSTRUMENT AND WITHIN 5 MINUTES THE SAME THING HAPPENED TO THIS INSTRUMENT. THE CIRCULATOR DESCRIBES THE WIRE AS A BRAIDED WIRE CABLE AND THAT THE CABLE WAS DANGLING. ANOTHER INSTRUMENT WAS OPENED WHICH FUNCTIONED APPROPRIATELY AND THE MD WAS ABLE TO FINISH THE PROCEDURE. HOWEVER, THERE WAS THE POTENTIAL FOR A FRAGMENT TO FALL INTO THE PATIENT.======================MANUFACTURER RESPONSE FOR SUTURING DEVICE FOR DAVINCI ROBOT, ENDOWRIST MEGA SUTURE CUT NEEDLE DRIVER======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER ENDOWRIST INSTRUMENT FOR DAVINCI NAY INTUITIVE SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR