BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3963849 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04583
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE LABEL ON THE INSTRUMENT'S HOUSING IS ILLEGIBLE AND LOOKS BARE. IT WAS CONCLUDED THAT THE FAILURE MODE LIKELY OCCURRED BECAUSE SMALL BUBBLES FORMED ON THE HOUSING'S MATERIAL DURING REPROCESSING. A SMALL HAIRLINE CRACK HAS FORMED NEAR THE GREY BUTTONS AND A SHINY FILM HAS DEPOSITED ON THE INSTRUMENT'S CHASSIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE MAIN TUBE OF THE INSTRUMENT EXHIBITS A WHITE RESIDUE APPROXIMATELY 7MM BELOW THE DISTAL CLEVIS. IT WAS CONCLUDED THAT THIS LIKELY OCCURRED DURING REPROCESSING, WHILE THE INSTRUMENT WAS IN THE STERILIZATION TRAY, CAUSING MATERIAL FROM THE HOUSING TO TRANSFER TO THE INSTRUMENT'S MAIN TUBE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, WHITE RESIDUE ON THE INSTRUMENT'S HOUSING FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING OF THE LARGE NEEDLE DRIVER INSTRUMENT, IT NOTED THAT THE HOUSING EXHIBITED COSMETIC DAMAGE. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO A PATIENT AND THERE WAS NO ALLEGATION THAT THERE WAS ANY HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441127 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470006-04 S10131206 0001

    Patients

    Seq Age Sex Outcome Treatment
    1