BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2890327 · Received December 29, 2012

    Report

    Report Number
    2955842-2012-01479
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    February 9, 2012
    Report Date
    December 26, 2012
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIP CABLE WAS DERAILED AND FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE SECTIONS ARE IN VARIOUS LENGTHS STICKING OUT AT THE WRIST. THE IDLER PULLEY RIM AND FACE ALSO EXHIBITED DAMAGE. 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 S HYSTERECTOMY PROCEDURE, THE SURGEON COMPLAINED THAT THE MEGASUTURECUT NEEDLE DRIVE INSTRUMENT WAS NOT WORKING AT ITS BEST. THE MEGASUTURECUT NEEDLE DRIVE INSTRUMENT WAS REMOVED AND UPON INSPECTION IT WAS NOTED THAT THE CABLES ON THE INSTRUMENT WERE TWISTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH AN INSTRUMENT OF A DIFFERENT TYPE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10110425 891

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES