BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3892849 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03878
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE GRIP CABLE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION NOT REPORTED WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING / MISUSE. 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. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE AND THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, 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 A DA VINCI PYELOPLASTY PROCEDURE, THE CABLE BROKE AT TIP OF THE MEGA NEEDLE DRIVER INSTRUMENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A DIFFERENT INSTRUMENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369208 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10140219 589

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR