BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLEDRIVER INSTRUMENT

    MDR report key: 3000117 · Received March 8, 2013

    Report

    Report Number
    2955842-2013-00777
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    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 IDLERS. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE SURFACE OF THE DISTAL PULLEY ALSO EXHIBITED SCRATCHES. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE CABLE ON THE MEGASUTURECUT NEEDLEDRIVER INSTRUMENT WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99801 MEGASUTURECUT NEEDLEDRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420309-01 M10121016 982

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG. SYS.| INSTRUMENT| ACCESSORIES