BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VESSEL SEALING INSTRUMENT

    MDR report key: 2981169 · Received February 27, 2013

    Report

    Report Number
    2955842-2013-00653
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI SURGICAL PROCEDURE, THE CUSTOMER NOTED BROKEN WIRES ON THE VESSEL SEALING INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84268 VESSEL SEALING INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 S10121107

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES