BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3190548 · Received June 26, 2013

    Report

    Report Number
    2955842-2013-02297
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    January 8, 2013
    Report Date
    May 31, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP CLOSE CABLE WAS BROKEN NEAR THE PROXIMAL PULLEYS AND PROXIMAL CLEVIS CABLE HOLE. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. NO MAJOR WEAR WAS FOUND ON THE PROXIMAL CLEVIS CABLE HOLE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION 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 SI PARTIAL NEPHRECTOMY PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT CABLE BROKE. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291283 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10121004 557

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES