BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM NEEDLE DRIVER INSTRUMENT

    MDR report key: 2880460 · Received December 19, 2012

    Report

    Report Number
    2955842-2012-01370
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THE NEEDLE DRIVER INSTRUMENT HAD A BROKEN TIP. NO OTHER INFORMATION WAS PROVIDED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THIS MEDWATCH REPORT IS LATE DUE TO A PROCESSING OVERSIGHT BY THE RESPONSIBLE CUSTOMER SERVICE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420117-04 S10100630 574

    Patients

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