BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3023651 · Received March 27, 2013

    Report

    Report Number
    2955842-2013-00972
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 25, 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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY WAS ABLE TO SPIN FREELY AND IT WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS SURFACE SCRATCHES ON THE DISTAL PULLEY. 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 DA VINCI SI SACROCOLPOPEXY PROCEDURE, WHILE FINISHING SUTURING MESH, THE CUSTOMER NOTICED A WIRE PROTRUDING FROM DISTAL TIP OF THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126765 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121210 777

    Patients

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