BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3964827 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04595
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE WRIST. OTHER CABLES AT WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THE INSTRUMENT DISTAL PULLEY HAD MECHANICAL INDENTATION/BURRS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THE INDENTATIONS/BURRS WERE DUE TO MISHANDLING/MISUSE. ADDITIONALLY FAILURE ANALYSIS OBSERVED THE INSTRUMENT MAIN TUBE TO HAVE SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVED AND ROUGH SURFACE FINISH. THE SCRATCH WAS SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE BROKEN CABLE AND MAIN TUBE DAMAGE WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT'S CABLE WAS FRAYED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442232 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-04 M10140414 960

    Patients

    Seq Age Sex Outcome Treatment
    1