BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1071666 · Received July 8, 2008

    Report

    Report Number
    2955842-2008-01122
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    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 DISTAL IDLERS CAUSING THE PULLEY TO SPIN FREELY. CABLE WEAR ON THE PULLEYS COMBINED WITH HIGH DRIVE TORQUES LIKELY CONTRIBUTED TO THE CABLE BREAKAGE. ENGINEERING ALSO OBSERVED THE MAIN TUBE HAS A SECTIONS WITH MATERIAL REMOVED. ONE SECTION HAS MATERIAL REMOVAL ALL AROUND THE TUBE BETWEEN THE MIDPOINT AND THE TUBE EXTENSION. THE DAMAGED AREAS ARE PARALLEL TO THE TUBE AXIS WITH A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. THE OTHER DAMAGED SECTION IS ABOVE THE MIDPOINT OF THE TUBE, OUT OF RANGE OF THE DISTAL TIP OF A CANNULA. ENGINEERING CONCLUDED THAT THIS TUBE DAMAGE MAY BE FROM CLEANING OR PRESSURE AGAINST THE INTERNAL BOWL AND TUBE TRANSITION OF THE CANNULA. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, A CABLE ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT OF THE SAME TYPE. 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 0711219 453

    Patients

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