BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3912316 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04073
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S 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 DID NOT EXHIBIT ANY WEAR. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE AND VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, AN UNIDENTIFIED ISSUE OCCURRED WITH THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. INITIAL REPORTER INDICATED THAT A WIRE WAS MISSING FROM THE INSTRUMENT. 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
    391375 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121106 765

    Patients

    Seq Age Sex Outcome Treatment
    1