BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1932278 · Received December 17, 2010

    Report

    Report Number
    2955842-2010-00554
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF THE TIP COVER IS RETURNED FOR EVALUATION, A FOLLOW-UP MDR WILL BE SUBMITTED. THE INSTRUMENT USED IN CONJUNCTION WITH THE TIP COVER WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT DOES NOT EXHIBIT EVIDENCE OF ARCING OR DAMAGE. THE TUBE EXTENSION AND GRIP SCISSOR TIPS DO NOT HAVE AN ARC TRACK. THE INSTRUMENT ALSO PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH AN MCS TIP COVER ACCESSORY INSTALLED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT 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 NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DA VINCI S SURG SYS, MCS INSTRUMENT, ACCSS, ESU