BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERTACCESSORY

    MDR report key: 1770709 · Received July 27, 2010

    Report

    Report Number
    2955842-2010-00330
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    March 18, 2010
    Report Date
    June 23, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDE IN THE MAUDE EVENT REPORT, INTUITIVE SURGICAL IS UNABLE TO PROVIDE ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF OUR COMPLAINT DATABASE WAS PERFORMED; HOWEVER, THERE WAS NO SIMILAR EVENT FOUND RELATED TO THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, INTUITIVE SURGICAL, INC. RECEIVED A MAUDE EVENT REPORT (FOI) FOR VOLUNTARY REPORT (B)(4) FROM THE FDA. THE EVENT DETAILS ARE PROVIDED BELOW: DURING A SURGICAL PROCEDURE THE DA VINCI HARMONIC INSTRUMENT FELL APART. THE END JAW PIECE WAS FOUND IN THE PT AND REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERTACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169 M10090615

    Patients

    Seq Age Sex Outcome Treatment
    1 DV SURGICAL SYSTEM, ACCESSORIES & ESU.