BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1844407 · Received September 24, 2010

    Report

    Report Number
    2955842-2010-00404
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 27, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF THE ACCESSORY IS RETURNED FOR EVALUATION A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH AN MCS TIP COVER ACCESSORY INSTALLED. THE MCS TIP COVER ACCESSORY WAS REPLACED TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-07 C10096

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR DA VINCI SYSTEM, INSTRUMENTS & ESU