BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2880663 · Received December 19, 2012

    Report

    Report Number
    2955842-2012-01377
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 10, 2012
    Report Date
    January 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLER PULLEY. THE IDLER PULLEY SPUN FREELY BUT WAS DAMAGED ON THE EDGE AND ON THE SURFACE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED SEEING A BROKEN CABLE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120710 505

    Patients

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