BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3081347 · Received April 26, 2013

    Report

    Report Number
    2955842-2013-01416
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH THE CERAMIC SLEEVE BROKEN AT THE BASE OF THE SPATULA, WITH MATERIAL REMOVED. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO EXCESS CONTACT AND MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, PIECES OF INSULATION FELL OFF THE PERMANENT CAUTERY SPATULA INSTRUMENT. THERE WERE NO MISSING PIECES OR PIECES FALLING INTO THE PATIENT REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182603 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10121025 311

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES ESU