BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER

    MDR report key: 2930302 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00300
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED A FRAYED WIRE; HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A BROKEN GRIP CABLE. BASED ON THIS CLARIFICATION, THE CUSTOMER REPORTED COMPLAINT IS CONFIRMED. ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY WAS FOUND TO SPIN FREELY AND WAS NOT DAMAGED. A CABLE SEGMENT WAS OBSERVED TO BE STICKING OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONAL FINDING: SCRATCHES WERE OBSERVED ON THE SURFACE OF THE DISTAL PULLEY. 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED SEEING FRAYED WIRES AT THE DISTAL END OF A MEGASUTURE NEEDLE DRIVER INSTRUMENT. THERE WERE NO MISSING 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
    35771 MEGASUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M20120413 309

    Patients

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