BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3151021 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02032
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS PULLEY. THE IDLER PULLEY SPUN FREELY BUT HAD DAMAGE ON THE SURFACE. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENTS WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. 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.

    Additional Manufacturer Narrative · 1

    RECEIVED (B)(4) FROM THE FDA IN WHICH THE CUSTOMER REPORTED (B)(6) 2013 AS THE EVENT DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI INGUINAL HERNIA REPAIR PROCEDURE A WIRE BROKE ON A 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
    250442 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130208 463

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES