BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2832468 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00914
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIP CABLE IS DERAILED ON THE DISTAL CLEVIS EAR THAT CAUSED THE WIRE TO STICK OUT. THE CABLE DERAILMENT IS LIKELY DUE TO THE CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. ENGINEERING EVALUATION FOUND THAT THE SAME GRIP CABLE IS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. THE INSTRUMENT ALSO EXHIBITS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL, SUGGESTING THE INSTRUMENT COLLISIONS OR ROUGH HANDLING OCCURRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE WIRES WERE OBSERVED TO BE STICKING OUT AT THE TIP OF THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING 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
    1 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10111209 939

    Patients

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