BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1903083 · Received November 12, 2010

    Report

    Report Number
    2955842-2010-00495
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE TUBE EXTENSION IS DISLODGED FROM THE MAIN TUBE. THE ENTIRE TUBE EXTENSION IS CIRCUMFERENTIALLY BROKEN AT THE BASE OF THE AXIAL KEYS AND AS A RESULT, THE TUBE EXTENSION CAN BE ROTATED 360 DEGREES. NO PIECES ARE MISSING. ENGINEERING ALSO OBSERVED CHAR MARKS ON THE OUTER SURFACE OF THE DISTAL END OF THE MAIN TUBE. THE INSTRUMENT WAS DISASSEMBLED TO FIND ADDITIONAL CHAR MARKS ON THE HYPOTUBES AND ON THE INNER SURFACE OF THE METAL REINFORCEMENT RING. THE CHAR MARKS LEADS ENGINEERING TO CONCLUDE THAT THE INSTRUMENT MAY HAVE ARCED DURING A PREVIOUS SURGICAL PROCEDURE AND THE ARCING MOST LIKELY OCCURRED AFTER THE TUBE EXTENSION BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT IN A DA VINCI SI HYSTERECTOMY PROCEDURE, IT WAS NOTICED THAT THE INSULATION WAS BENT AT THE LOCATION WHERE THE JOINTS MEET. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE CUSTOMER REPORTED MALFUNCTION DOES NOT IN ITSELF CONSTITUTE AN FDA REPORTABLE EVENT, HOWEVER, ENGINEERING DISCOVERED EVIDENCE OF ARCING DURING INTERNAL EVALUATION OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420179-09 M10100301 480

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| ESU| DA VINCI SI SYSTEM