BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM NEEDLE DRIVER INSTRUMENT

    MDR report key: 1952970 · Received January 7, 2011

    Report

    Report Number
    2955842-2011-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K990144
    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 FOUND ONE GRIP TO BE DETACHED FROM THE DISTAL END OF THE 5MM NEEDLE DRIVER INSTRUMENT. THE CARBIDE INSERT WAS FOUND TO STILL BE ATTACHED TO THE GRIP. THE GRIP FRACTURED AT THE JUNCTION WITH THE HUB FEATURE, WHERE THERE IS A 90 DEGREE ANGLE, AND HAIRLINE CRACKING IS EXHIBITED. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S TUBAL REANASTOMOSIS PROCEDURE, WHILE THE SURGEON WAS SUTURING, THE TIP OF THE 5MM NEEDLE DRIVER INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE EVENTS, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420117-04 S10091120 013

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR DA VINCI S SYSTEM, INSTRUMENTS AND ACCESSORIES