BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3950456 · Received July 22, 2014

    Report

    Report Number
    2955842-2014-04480
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI INCISIONAL HERNIA REPAIR, THE LARGE NEEDLE DRIVER INSTRUMENT'S WIRE WAS EXPOSED AND COMPLETELY SNAPPED. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. INTUITIVE SURGICAL HAS ATTEMPTED TO CONTACT THE SITE TO CONFIRM AFTER PROCEDURE WAS COMPLETED IF ANY FRAGMENTS FELL INSIDE THE PATIENT OR ADVERSE OUTCOME TO THE PATIENT. NO RESPONSE FROM THE SITE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427658 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 N10140327 426

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR