BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1052766 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01028
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE PITCH UP CABLE IS BROKEN AT THE DISTAL CLEVIS. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. ENGINEERING CONCLUDED THAT THE CABLE MAY HAVE BROKE DUE TO REPEATED LIFTING OF HEAVY TISSUE MASS. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE HAS VARIOUS DEEP SCRATCHES WITH LIGHT MATERIAL REMOVED. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE SCRATCHES ARE MOST LIKELY DUE TO INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. 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 PK DISSECTING FORCEPS INSTRUMENT HAS A BROKEN WIRE. 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 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 0610071 405

    Patients

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