BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER

    MDR report key: 2880017 · Received December 19, 2012

    Report

    Report Number
    2955842-2012-01364
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 26, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND IT WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI MYOMECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT CABLE BROKE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGASUTURECUT NEEDLE DRIVER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10111214 278

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES