BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3211882 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02464
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE GRIP OPEN AND CLOSE CABLES ATTACHED TO ONE CABLE CRIMP WERE BROKEN. THE BROKEN GRIP OPEN CABLE STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS A DISLODGED CABLE CRIMP. THE GRIP CRIMP THAT CONTAINS THE BROKEN CABLE SEGMENTS WAS MISSING FROM THE GRIP'S CRIMP POCKET. THE CRIMP LIKELY BECAME DISLODGED AFTER THE GRIP CABLE BROKE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE AND MISSING CRIMP, 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

    IT WAS REPORTED THAT DURING A DA VINCI S TOTAL HYSTERECTOMY PROCEDURE A CABLE BROKE ON A MEGA SUTURECUT NEEDLE DRIVER 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
    308645 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121108 248

    Patients

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