BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3830868 · Received May 23, 2014

    Report

    Report Number
    2955842-2014-03205
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF END TIP BROKE. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT WAS INSPECTED UNDER A DIGITAL MICROSCOPE AND THE TIP WAS NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION FOUND THE GRIP CABLE TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT WAS OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. THE DISTAL CLEVIS HUB DID NOT EXHIBIT ANY WEAR. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, IT WAS IDENTIFIED THAT THE END TIP BROKE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND CUSTOMER CONFIRMED THAT THE TIP OF THE INSTRUMENT WOULD NOT ARTICULATE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307420 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130717 093

    Patients

    Seq Age Sex Outcome Treatment
    1