BEUDAMED
    FDA Adverse Event Other Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1031777 · Received April 18, 2008

    Report

    Report Number
    2955842-2008-00192
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 18, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESSORY AND INSTRUMENT HAVE NOT BEEN RETURNED FOR EVAL. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED, HOWEVER, THE ACCOUNT INDICATED THAT THE ELECTRO SURGICAL GENERATOR SETTINGS USED DURING THE SURGICAL PROCEDURE WERE SET AT 45 WATTS WHICH IS HIGHER THAN ISI'S RECOMMENDED SETTINGS. IF THE ACCESSORY OR INSTRUMENT ARE RETURNED FOR EVAL, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOWARDS THE MIDDLE OF A DA VINCI S HYSTERECTOMY PROCEDURE, WHILE PERFORMING A RIGHT PELVIC LYMPHADENECTOMY USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT (MCS) WITH THE TIP COVER ACCESSORY INSTALLED, THE PATIENT'S RIGHT ILIAC VEIN AND ARTERY WERE CAUTERIZED. THE PLANNED PROCEDURE WAS COMPLETED WITH A REPLACEMENT TIP COVER ACCESSORY AND DELAYED 30 MINUTES AS THE SURGEON STITCHED THE BURNT BOWEL. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURGICAL SYSTEM| CANNULA ACCESSORY| MCS INSTRUMENT| ELECTROSURGICAL UNIT