BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3183038 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02261
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THERE WAS A FRAYED GRIP CLOSE CABLE NEAR THE DISTAL IDLER PULLEY. THE FRAYED STRANDS WERE STICKING OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS A DERAILED CABLE. THE SAME FRAYED GRIP CLOSE CABLE WAS DERAILED FROM THE DISTAL IDLER PULLEY. GRIPS WERE STILL ABLE TO OPEN AND CLOSE BUT MOVEMENT MAY NOT BE PRECISE. EVIDENCE NOT CONCLUSIVE, BUT CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE END OF A DA VINCI SI HYSTERECTOMY PROCEDURE, THE USER FACILITY NOTICED A BROKEN CABLE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    282528 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121030 637

    Patients

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