BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM CAUTERY SPATULA TIP ACCESSORY

    MDR report key: 2082089 · Received May 9, 2011

    Report

    Report Number
    2955842-2011-00134
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VIDEO OF THE SURGICAL PROCEDURE WAS PROVIDED TO INTUITIVE SURGICAL BY THE HOSPITAL. ENGINEERING REVIEWED THE VIDEO AND OBSERVED THAT ON MULTIPLE OCCASIONS THE SURGEON ACTIVATED THE ENERGY FOR THE 5MM MONOPOLAR CAUTERY INSTRUMENT WITH A BIPOLAR INSTRUMENT IN CLOSE PROXIMITY TO ITS SPATULA TIP. AS A RESULT, THE SPATULA TIP ARCS TO THE BIPOLAR INSTRUMENT AT VARIOUS TIMES, CONSEQUENTLY DEGRADING THE INSULATION BARRIER ON THE SPATULA AND LEADING TO THE MALFUNCTION EXPERIENCED BY THE CUSTOMER. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES IN THE 5MM MONOPOLAR CAUTERY INSTRUCTIONS FOR USE: WARNING: AS WITH ANY CAUTERY DEVICE, IT IS POSSIBLE FOR ENERGY TO DISCHARGE IN AN AREA OTHER THAN THE INSTRUMENT TIP. IT IS IMPORTANT TO EXERCISE CAUTION WHEN USING AN ENERGIZED ENDOWRIST 5 MM MONOPOLAR CAUTERY INSTRUMENT TO HELP AVOID UNINTENDED CONTACT WITH TISSUE ADJACENT TO THE AREA TO BE CAUTERIZED.

    Additional Manufacturer Narrative · 1

    CORRECTION: A NON-ENERGY INSTRUMENT WAS USED WITH THE 5MM MONOPOLAR CAUTERY SPATULA INSTRUMENT WHEN THE INCIDENT OCCURRED. MEDWATCH MFR REPORT 2955842-2011-00134, FOLLOW-UP 01, INDICATED THAT AN ENERGY (BIPOLAR) INSTRUMENT WAS USED. ADDITIONAL INFORMATION: FURTHER EVALUATION OF THE SURGICAL PROCEDURE VIDEO WAS PERFORMED BY ENGINEERING. WHILE REVIEWING THE VIDEO, ENGINEERING OBSERVED THAT THE NON-ENERGY INSTRUMENT WAS USED REPEATEDLY TO SCRAPE OFF/CLEAN THE SPATULA TIP, WHICH COULD HAVE CONTRIBUTED TO THE TIP DAMAGE. PRIOR TO THE INCIDENT OCCURRING, MULTIPLE ARCING EVENTS WERE OBSERVED AND CHUNKS OF SILICONE FROM THE TIP HAD FALLEN OFF OF THE SPATULA AND WERE VISIBLE IN THE SURGEON'S FIELD OF VIEW. THE INSTRUMENT DAMAGE CAN CLEARLY BE SEEN, HOWEVER, THE SURGEON CONTINUES TO OPERATE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES UNDER GENERAL PRECAUTIONS AND WARNINGS: - DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND TIP ACCESSORY WERE RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED LOCALIZED MELTING WITH MATERIAL REMOVED ON ONE SIDE OF THE PLASTIC SLEEVE OF THE SPATULA TIP. THE DAMAGE INDICATES THAT AN ARCING EVENT OCCURRED. THE INSTRUMENT WAS ALSO INSPECTED AND NO PHYSICAL DAMAGE WAS OBSERVED. ENGINEERING PERFORMED FUNCTIONAL TESTS WITH THE INSTRUMENT USING A NEW SPATULA TIP AND THE CAUTERY PERFORMED AS INTENDED WITH NO OCCURRENCE OF ARCING. ADDITIONAL INVESTIGATION WAS PERFORMED BY A FIELD SERVICE ENGINEER, WHO WENT ONSITE AND EVALUATED THE SYSTEM. NO ERRORS WERE FOUND WHEN REVIEWING THE SYSTEM ERROR LOGS AND NO ISSUES WERE OBSERVED DURING INSPECTION OF THE SYSTEM ARM THAT THE INSTRUMENT WAS INSTALLED ON DURING THE SURGICAL PROCEDURE. THE ELECTROCAUTERY CABLES WERE ALSO INSPECTED AND NO DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE RESECTING TISSUE DURING A DA VINCI SI TONGUE BASE RESECTION PROCEDURE, THE SURGEON OBSERVED A FLAME ON THE 5MM CAUTERY SPATULA TIP ACCESSORY THAT WAS INSTALLED ON THE 5MM MONOPOLAR CAUTERY INSTRUMENT. THE INSTRUMENT AND TIP ACCESSORY WERE IMMEDIATELY REMOVED AND REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT AND TIP ACCESSORY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM CAUTERY SPATULA TIP ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400160-02 C10320

    Patients

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