BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER

    MDR report key: 2895890 · Received January 4, 2013

    Report

    Report Number
    2955842-2013-00056
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 10, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A FRAYED CABLE AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE SECTION IS APPROXIMATELY 0.05 IN LENGTH. THE IDLER PULLEY WAS FOUND WITH INDENTATION ON THE SURFACE AND THE EDGE. THE INSTRUMENT HAS 3 USES REMAINING. 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 S SURGICAL PROCEDURE, THE WIRES WERE LOOSE AT THE TIP OF THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5062 MEGA SUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10100730 564

    Patients

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