BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1960583 · Received January 13, 2011

    Report

    Report Number
    2955842-2011-00011
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY AND MONOPOLAR CURVED SCISSORS INSTRUMENT HAVE NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED, HOWEVER, THE ISI REPRESENTATIVE PRESENT DURING THE EVENT STATED THAT THROUGHOUT THE PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED WERE BEING COMPROMISED DUE TO THE MOVEMENT OF THE PATIENT'S LARGE ORGAN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE HOUR DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF WITNESSED AN ARC OF ENERGY FROM THE MONOPOLAR CURVED SCISSORS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED, TO THE PATIENT'S UTERUS. NO INTERVENTION OR REPAIR WAS REQUIRED AS THE UTERUS WAS BEING REMOVED. APPROXIMATELY 2 HOURS LATER IN THE PROCEDURE, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES DUE TO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED AND NO PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES