BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED BIPOLAR DISSECTORINSTRUMENT

    MDR report key: 2232039 · Received September 1, 2011

    Report

    Report Number
    2955842-2011-00286
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED BURN MARKS AT BOTH GRIP TIPS AND AT THE BASES OF THE GRIP JAWS. MELTED MATERIAL WAS ALSO OBSERVED AT THE YAW PULLEY. THE DAMAGE INDICATES THAT AN ARCING EVENT OCCURRED. INTUITIVE SURGICAL INTERNAL LABORATORY TESTING HAS DETERMINED THAT THE OBSERVED ARC TRACK FAILURE MODE IS MOST LIKELY TO OCCUR WHEN A BIPOLAR INSTRUMENT IS ENERGIZED WITH THE GRIPS IN A WIDE-OPEN POSITION WITH NO TISSUE BETWEEN THE GRIPS. INTERNAL ARCING OF BIPOLAR INSTRUMENTS RESULTS IN A POTENTIAL LOSS OF PRODUCT FUNCTION, BUT NO TRANSFER OF ENERGY TO THE PATIENT. INTUITIVE SURGICAL HAS CONCLUDED THAT THE LIKELIHOOD OF INJURY DUE TO THIS FAILURE IS REMOTE. USERS ARE INSTRUCTED TO RETAIN BACK-UP INSTRUMENTS IN CASE AN INSTRUMENT FAILS TO PERFORM AND ARE ALSO INSTRUCTED IN PROPER TECHNIQUE TO MINIMIZE THE LIKELIHOOD OF INTERNAL ARCING.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, A SPARK WAS OBSERVED COMING FROM THE CURVED BIPOLAR DISSECTOR INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION FROM THIS SITE HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED BIPOLAR DISSECTORINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420344-02 S10110623 866

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, ACCS., & ESU