BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2132954 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00181
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING NOTICED THE CARBIDE INSERT DETACHED FROM ONE OF THE INSTRUMENT GRIPS AND NO ADHESIVE RESIDUE WAS OBSERVED ON THE GRIP TIP SURFACE. THE DETACHED INSERT WAS RETURNED WITH THE INSTRUMENT. NO DAMAGE WAS FOUND ON THE INSERT ON THE OTHER GRIP TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY, THE PLATE INSIDE TIP OF THE MEGA NEEDLE DRIVER INSTRUMENT CAME OFF, FELL INTO THE PATIENT AND WAS RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10110330 174

    Patients

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