BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENDOWRIST MEGA SUTURECUT

    MDR report key: 3792083 · Received April 21, 2014

    Report

    Report Number
    3792083
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 21, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING ROBOTIC ASSISTED LAPAROSCOPIC MYOMECTOMY. DURING THE PROCEDURE, AN ARM #3 THE SCISSORS WERE USED TO CREATE A LONGITUDINAL VERTICAL INCISION AND CONTINUED DISSECTION THROUGH THE MYOMETRIUM UNTIL THE FIBROID WAS REACHED. DURING THIS PROCESS, THE WIRE BROKE ON THE MEGA SUTURE CUT. MEGA SUTURE CUT REMOVED FROM FIELD. SURGEON LOOKED IN ABDOMEN FOR ANY BROKEN PARTS. NONE FOUND. EVENT WAS REPORTED TO INTUITIVE. PATIENT DID NOT SUSTAIN ANY INJURY AND CASE COMPLETED SUCCESSFULLY. THIS WAS A NEAR MISS. THERE WAS ONE LIFE LEFT ON THE MEGA SUTURE CUT DEVICE PRIOR TO START OF CASE.MANUFACTURER RESPONSE FOR INTUITIVE MEGA SUTURE CUT, MEGA SUTURE CUT (PER SITE REPORTER).====================== NO RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240951 DA VINCI ENDOWRIST MEGA SUTURECUT SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL N/A M10140211 609

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR LAPAROSCOPIC TENACULUM.| ROBOTIC ARM # 2 HAD THE THE PK, ARM # 3 HAD THE