BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1061798 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01064
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE GRIP CLOSE CABLE IS BROKEN AT THE SCISSOR GRIP. THE GRIP HUB HAS A PEAK ACROSS THE CABLE GROOVE AND THE WEAR AGAINST THIS PEAK MOST LIKELY CONTRIBUTED TO THE BREAKAGE. ENGINEERING ALSO OBSERVED THAT THE MAIN TUBE HAS VARIOUS SECTIONS ABOVE AND BELOW MIDPOINT WITH LIGHT MATERIAL REMOVED. THE DAMAGED AREAS ARE PARALLEL TO THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THESE SCRATCHES ARE MOST LIKELY CAUSED BY A CANNULA ACCESSORY. THE TUBE DAMAGE ABOVE THE MIDPOINT MAY HAVE BEEN CAUSED BY THE CLEANING PROCESS. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE CABLE OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT BROKE, HOWEVER, NOTHING FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. 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 0710231 847

    Patients

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