BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3930992 · Received July 13, 2014

    Report

    Report Number
    2955842-2014-04243
    Event Type
    Malfunction
    Date Received
    July 13, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLER. THE IDLER PULLEY SPUN FREELY AND DOES NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S GRIP CABLECOULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT CABLE POPPED DURING SUTURING/SEWING. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409021 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10131107 452

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR