BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER

    MDR report key: 2945509 · Received February 6, 2013

    Report

    Report Number
    2955842-2013-00417
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CHECKED FOR INSTRUMENT RECOGNITION ON AN IN-HOUSE SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED INSTRUMENT, SHOWING 4 USES LEFT. POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. THE DALLAS CHIP PROGRAMMER (DCP) VERIFICATION OF INSTRUMENT PASSED. THE INSTRUMENT WAS FOUND WITH MAIN TUBE BROKEN AT THE MID POINT OF THE SHAFT. EVIDENCE WAS NOT CONCLUSIVE, BUT DAMAGE LIKELY DUE TO EXCESS FORCE APPLIED NORMAL TO THE MAIN TUBE. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. 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 SI SURGICAL PROCEDURE, THE LARGE NEEDLE DRIVER INSTRUMENT COULD NOT BE RECOGNIZED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50789 LARGE NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10120803 556

    Patients

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