BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 2132662 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00180
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 19, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED A CHAR MARK ON THE YAW PULLEY AND YAW PULLEY EXIT. THE CONDUCTOR WIRE HAS SURFACE DAMAGE BUT IS NOT BROKEN. THE CERAMIC SLEEVE ALSO EXHIBITS DAMAGE. NO OTHER DAMAGE FOUND. THE CHARRING INDICATES AN ARCING EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE PERMANENT CAUTERY HOOK INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400183-02 M10100728 534

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SYS, INSTRUMENTS, ACCESSORIES, & ESU