BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1071664 · Received July 8, 2008

    Report

    Report Number
    2955842-2008-01121
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND ONE PITCH UP CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. ENGINEERING CONCLUDED THAT THE CABLE LIKELY BROKE FROM OVERLOAD IN TENSION. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS VARIOUS DEEP SCRATCHES WITH MATERIAL REMOVED. THE SCRATCHES ARE NARROW AND NOT ALIGNED WITH THE TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS 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 DURING A DA VINCI S LOBECTOMY PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT DID NOT REACT TO MOVEMENTS OF ARTICULATION. 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 HOOK INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420183-04 0801041 731

    Patients

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