BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3090838 · Received May 2, 2013

    Report

    Report Number
    2955842-2013-01522
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE COMPLAINT OF FRAYED WIRES WAS CONFIRMED. 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 INSTRUMENTS WRIST. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS PROXIMAL CLEVIS WEARING. THE PROXIMAL CLEVIS CABLE HOLE EXHIBITED WEAR ON ONE EDGE. OTHER CABLES AT THE INSTRUMENTS WRIST WERE NOT DAMAGED. EVIDENCE IS NOT CONCLUSIVE BUT WEAR ON THE HOLE MAY HAVE CONTRIBUTED TO THE CABLE BREAKAGE. 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 AFTER A DA VINCI SI SURGICAL PROCEDURE, FRAYED WIRES WERE IDENTIFIED IN CENTRAL PROCESSING ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES 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
    192371 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10110824 817

    Patients

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