BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3791262 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02796
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. ONE GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. THE DISTAL CLEVIS HUB DID NOT EXHIBIT ANY WEAR. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE GRIP CABLE WAS ALSO DERAILED AT THE DISTAL IDLER PULLEY. THE GRIP CABLE WAS SEATED ON OUTERMOST PULLEY AND THE CABLE WAS EXPOSED ON THE OUTSIDE OF PULLEY. YAW MOTION WAS NON-INTUITIVE AS A RESULT. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE COULD LIKELY 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, A WIRE SNAPPED ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    268696 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10131101 177

    Patients

    Seq Age Sex Outcome Treatment
    1