BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA

    MDR report key: 2834438 · Received November 15, 2012

    Report

    Report Number
    2955842-2012-00943
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH PROXIMAL CLEVIS BROKEN OFF THE MAIN TUBE COMPLETELY. A PIECE OF THE CLEVIS, APPROXIMATELY 0.3 X 0.17 IN SIZE, HAD BROKEN OFF THE CLEVIS. EVIDENCE IS NOT CONCLUSIVE, BUT DAMAGE LIKELY DUE TO EXCESS FORCE APPLIED NORMAL TO THE CLEVIS. THE INSTRUMENT HAS 9 USES REMAINING. A CALL WAS MADE OUT TO THE CUSTOMER ON (B)(4) 2012 TO FOLLOW UP ON THE REPORTED COMPLAINT. IT WAS STATED THAT THE PLASTIC TIP OF THE INSTRUMENT BROKE, PREVENTING IT TO COME OUT OF THE CANNULA. THUS, THE ENTIRE ARM WAS PULLED OUT OF THE PATIENT, AND THE INSTRUMENT WAS BROKEN IN HALF TO REMOVE IT FROM THE CANNULA, AS IT WAS STUCK. THE INSTRUMENT WAS BROKEN IN HALF OUTSIDE OF THE PATIENT. THE REPORTER CONFIRMED THAT NO PIECES WERE OBSERVED FALLING INTO THE PATIENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT'S PLASTIC PIECE BROKE ON THE TIP, CAUSING INSTRUMENT TO GET STUCK IN THE CANNULA. AFTER THE CANNULA AND THE INSTRUMENT WERE REMOVED, THE INSTRUMENT WAS CUT IN HALF TO REMOVE IT FORM THE CANNULA. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-04 S10090109 558

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES