BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO WRIST ONE SUCTION IRRIGATOR INSTRUMENT

    MDR report key: 3243930 · Received July 23, 2013

    Report

    Report Number
    2955842-2013-02699
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 26, 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. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS RETURNED WITH THE DISTAL TIP DETACHED FROM THE SHAFT. THE DRIVE CABLES HAD BEEN CUT. A MIDDLE SNAKE WRIST DISC EXHIBITED SCRATCH MARKS ON ONE SIDE AND THE PLASTIC TIP ALSO EXHIBITED GOUGE MARKS AROUND THE INTERFACE WITH THE END CAP. ENGINEERING CONCLUDED THE LIKELY FAILURE MODE WAS A DISLODGED SNAKE WRIST DISC, WHICH RESULTED IN AN INABILITY TO REMOVE INSTRUMENT FROM CANNULA. NO OTHER DAMAGE WAS FOUND. 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 TOTAL HYSTERECTOMY PROCEDURE THE SNAKE WRIST GOT STUCK IN THE TROCAR ON A ENDO WRIST ONE SUCTION IRRIGATOR INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES 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
    343069 ENDO WRIST ONE SUCTION IRRIGATOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410299-02 M10120910 964

    Patients

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