BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 2182675 · Received July 28, 2011

    Report

    Report Number
    2955842-2011-00246
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE INSTRUMENT TO BE RETURNED WITH THE CARBIDE INSERT DETACHED FROM ONE GRIP. A SMALL PIECE OF THE CORNER OF THE INSERT REMAINS ATTACHED TO THE GRIP. THE BRAZING SURFACE OF GRIP HAS SOME VOIDS WITH MISSING FILLER MATERIAL AND THE OUTER SURFACE OF DAMAGED GRIP EXHIBITS SCRATCH MARKS. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS SUTURING WITH THE MEGA NEEDLE DRIVER INSTRUMENT, THE METAL PLATE BELOW THE JAW FELL OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, INJURY OR ADVERSE OUTCOME WAS 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 M10110321 137

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES