BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM DEBAKEY FORCEPS INSTRUMENT

    MDR report key: 1041295 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00253
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE MAIN TUBE HAS THREE SECTIONS WITH MISSING TUBE INSULATION. THE MISSING SECTIONS RANGE IN SIZE FROM .110 INCHES BY .90 INCHES TO .375 INCHES BY .100 INCHES. THE DAMAGED AREAS ARE LOCATED 3.6 INCHES ABOVE THE SNAKE WRIST ALL THE WAY UP TO THE MIDPOINT OF THE TUBE. NO OTHER DAMAGE FOUND. BASED ON THE LOCATION AND APPEARANCE, THE SCRATCHES ARE MOST LIKELY DUE TO INSTRUMENT COLLISIONS OR A CANNULA ACCESSORY. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE ENDOWRIST INSTRUMENT 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 THE DEBAKEY FORCEPS INSTRUMENT SHAFT IS SCRATCHED. 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 5MM DEBAKEY FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420145-04 1109071 828

    Patients

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