BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION/IRRIGATOR INSTRUMENT

    MDR report key: 3002737 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00814
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH THE DISTAL TIP AND INNER LUMEN DISLODGED FROM SNAKE WRIST DISK. THE MISSING DISTAL TIP THAT FELL INTO PATIENT WAS RETURNED, IT WAS TAPED TO SUCTION IRRIGATOR INSTRUMENT MAIN TUBE. THE INSTRUMENT'S SNAKE WRIST ALSO EXHIBITED A DISLODGED DISK. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO EXCESSIVE SIDE LOADING OR OTHER TYPE OF MISHANDLING. INSTRUMENT HAS NO REMAINING USES LEFT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE GRAY PART OF THE SUCTION IRRIGATOR INSTRUMENT'S TIP BROKE OFF FELL INTO PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105612 SUCTION/IRRIGATOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410299-02 M10120910 006

    Patients

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