BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3800657 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02862
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT STUCK OUT AT THE WRIST. NO DAMAGE OR WEAR MARKS WERE OBSERVED ON THE CLEVIS. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE AND/OR TUBE ABRASIONS WITH MATERIAL REMOVED, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROCESSING OF A DA VINCI MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, BROKEN WIRES WERE IDENTIFIED AT THE DISTAL TIP. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279108 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10131116 270

    Patients

    Seq Age Sex Outcome Treatment
    1