BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1001760 · Received February 19, 2008

    Report

    Report Number
    2955842-2008-00072
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Report Date
    February 15, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTING AND FOUND THAT THE JAWS OPENED AND CLOSED WITHOUT ISSUE. ENGINEERING ALSO OBSERVED THE TUBE EXTENSION IS SLIGHTLY DISLODGED FROM THE MAIN TUBE AND THE ENTIRE TUBE EXTENSION WALL IS BROKEN AT THE KEYS. THE DISTAL END OF THE MAIN TUBE AND THE TUBE EXTENSION HAVE BURNED SECTIONS. THE DISCOVERY HAS LED ENGINEERING TO CONCLUDE THAT THE INSTRUMENT MAY HAVE ARCED DURING A PREVIOUS SURGICAL PROCEDURE AND THE TUBE EXTENSION BREAKAGE MAY HAVE CREATED A PATH FOR ARCING TO OCCUR. NO OTHER DAMAGE FOUND

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WILL NOT OPEN AND CLOSE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 2106071 574

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM| ACCESSORIES