BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND DISSECTOR

    MDR report key: 2912378 · Received January 12, 2013

    Report

    Report Number
    2955842-2013-00166
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Date of Event
    November 22, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS ABLE TO CONFIRM THE REPORTED FAILURE MODE. THE MAIN INSULATION TUBE WAS FOUND TO BE DAMAGED AT THE DISTAL END. THE MAIN INSULATION TUBE SHOWED GOUGES ON ONE SIDE AND EXHIBITED A 0.195 X 0.065 PIECE MISSING ROUGHLY 6 ABOVE THE SNAKE WRIST. THERE WERE A COUPLE OF AREAS BELOW THIS SECTION WITH SCRATCHES ON THE MAIN INSULATION TUBE. THE CANNULA ACCESSORY USED WITH THIS INSTRUMENT WAS RETURNED AND INVESTIGATED UNDER MDR 2955842-2013-00156. DURING THE FAILURE ANALYSIS, THE ACCESSORY CANNULA WAS FOUND WITH DENTS ON THE DISTAL TIP OF THE CANNULA. A GAGE PIN COULD NOT BE PASSED THROUGH THE CANNULA TIP. ENGINEERING WAS ABLE TO CONFIRM THAT THE MAIN INSULATION DAMAGE FOUND ON THE INSTRUMENT WAS CAUSED BY THE CANNULA ACCESSORY. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DAVINCI SI SURGERY PROCEDURE, WHEN THE SURGICAL STAFF TRIED TO TAKE THE MARYLAND DISSECTOR INSTRUMENT OUT OF THE CANNULA, THEY NOTICED SHAVINGS FROM SHAFT. CUSTOMER INDICATED THAT NOTHING FELL INSIDE THE PATIENT AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19398 MARYLAND DISSECTOR ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420143-04 S10120217 272

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES