BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3180786 · Received June 20, 2013

    Report

    Report Number
    2955842-2013-02244
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 22, 2013
    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. ENGINEERING OBSERVED THE HOUSING WAS CRACKED AND THE CHASSIS WAS BROKEN. ONE INSTRUMENT LEVER WAS DISLODGED AND RETURNED WITH THE INSTRUMENT. THE BANANA PLUG WAS ALSO FOUND BENT AND DAMAGED. ADDITIONAL OBSERVATION WAS MAIN TUBE DAMAGE. THE MAIN TUBE INSULATION EXHIBITED A DAMAGED SECTION WITH TUBE INSULATION REMOVED APPROXIMATELY 1.38 FROM THE DISTAL END. MATERIAL WAS MISSING. SEVERAL DEEP SCRATCHES WERE OBSERVED AT THE DISTAL END AS WELL. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; MISSING TUBE INSULATION, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    A MONOPOLAR CAUTERY INSTRUMENT WAS RETURNED WITHOUT ANY EVENT INFORMATION. NO COMPLAINT WAS COMMUNICATED TO INTUITIVE SURGICAL REGARDING PERFORMANCE OF THE DA VINCI SURGICAL SYSTEM. NO MALFUNCTION OF THE DA VINCI SYSTEM WAS ALLEGED THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280195 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10110616 627

    Patients

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