BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 1041294 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00243
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED ONE OF THE DISTAL CLEVIS "EARS" AND THE CONDUCTOR CAP WERE MISSING. THE EAR WAS BROKEN OFF AT BASE AND IT APPEARS THAT THE BREAKAGE WAS MOST LIKELY DUE TO OVERLOADING OF THE TIP WITH THE WRIST PITCHED. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS A SECTION DIRECTLY ABOVE THE PROXIMAL CLEVIS WITH MATERIAL REMOVED ON ONE SIDE. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY AND INSTRUMENT COLLISIONS. 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 AND CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN, HOWEVER, THE PATIENT WAS NOT IMPACTED. 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 PERMANENT CAUTERY SPATULA INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420184-04 3108071 741

    Patients

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