BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3913842 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04081
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S GRIP CABLE WAS BROKEN. THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT WRIST. THE OTHER CABLES AT WRIST ARE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATIONS AND BURRS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. FAILURE ANALYSIS CONCLUDED THE MECHANICAL INDENTATION AND BURR DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY SURGICAL PROCEDURE, IT WAS NOTED THAT THE THREADS BROKE OFF ON THE MEGA SUTURECUT NEEDLE DRIVER. ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER STATED HE HAD NO RECOLLECTION IF ANY FRAGMENTS FELL INTO THE PATIENT, IF THERE WAS ANY ADVERSE OUTCOME OR INJURY TO THE PATIENT, HOWEVER, STATED THAT AS SOON AS THE SURGEON NOTED THAT THE CABLE WAS BROKEN, THE INSTRUMENT WAS REMOVED AND THE SURGEON IRRIGATED THE SITE. HE STATED THAT HE HAS SENT THE INSTRUMENT BACK TO INTUITIVE SURGICAL INC. FOR FAILURE ANALYSIS INVESTIGATION TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389947 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140217 329

    Patients

    Seq Age Sex Outcome Treatment
    1