BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3895202 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03920
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE DISTAL END OF THE MAIN TUBE HAD MICRO CRACKS. THE MICRO CRACKS RUN IN THE AXIAL DIRECTION AND MEASURED APPROXIMATELY 0.277. THESE TYPES OF MICRO CRACKS WILL NOT LEAD TO A MECHANICAL FAILURE OF THE INSTRUMENT, HOWEVER, THERE IS A POTENTIAL FOR INSULATION FAILURE AFTER REPROCESSING, RESULTING IN A PATHWAY FOR ELECTROSURGICAL ENERGY TO LEAK TO TISSUE AND POTENTIALLY CAUSE UNINTENDED INJURIES. THE LOCATION OF THESE MICRO CRACKS IS CONFINED TO 2 CM OF THE DISTAL END OF THE INSTRUMENT SHAFT.

    Description of Event or Problem · 1

    THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL AS PART OF THE FIELD ACTION NUMBER 2955842-051613-005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371919 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130409 794

    Patients

    Seq Age Sex Outcome Treatment
    1