BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3896976 · Received June 26, 2014

    Report

    Report Number
    2955842-2014-03939
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS BROKEN. ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE CABLE BROKE UNDER TENSILE LOADING. THE OTHER CABLES AT WRIST WERE NOT DAMAGED. FAILURE ANALYSIS CONCLUDED THE CABLE WEAR ON PULLEYS COMBINED WITH HIGH GRASPING FORCE AND LARGE FLEET ANGLE BETWEEN THE PROXIMAL AND DISTAL PULLEYS LIKELY CONTRIBUTED TO BREAKAGE. FAILURE ANALYSIS ALSO FOUND THE DISTAL PULLEY HAD MECHANICAL INDENTATIONS AND BURRS. THE DISTAL IDLER PULLEY ON WHICH THE BROKEN CABLE WAS SEATED HAD A SECTION THAT HAD AN INDENTATION ON THE EDGE. FAILURE ANALYSIS CONCLUDED THAT THE PULLEY DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE MEGA SUTURECUT NEEDLE DRIVER WAS RETURNED TO INTUITIVE SURGICAL INC. (ISI) WITHOUT A CUSTOMER REPORTED COMPLAINT. ON (B)(4) 2014, INTUITIVE SURGICAL INC (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER CONFIRMED THAT THE PLANNED HYSTERECTOMY SURGICAL PROCEDURE WAS COMPLETED AND NO FRAGMENTS FELL INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374864 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140305 428

    Patients

    Seq Age Sex Outcome Treatment
    1