BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED MARYLAND BIPOLAR INSTRUMENT

    MDR report key: 1070076 · Received July 3, 2008

    Report

    Report Number
    2955842-2008-01130
    Event Type
    Malfunction
    Date Received
    July 3, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, PERFORMANCE TESTING WAS CONDUCTED AND FOUND THE INSTRUMENT TO SUCCESSFULLY BE RECOGNIZED ON THE SYSTEM. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS WITH GRIPS OPENING AND CLOSING PROPERLY. THE POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. ENGINEERING WAS UNABLE TO REPLICATE THE RECOGNITION ISSUE. ENGINEERING ALSO OBSERVED THE MAIN TUBE TO HAVE A DEEP V-SHAPED SCRATCH WITH MATERIAL REMOVED LOCATED .250" ABOVE THE PROXIMAL CLEVIS. ENGINEERING CONCLUDED THAT THE SCRATCH WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS OR OTHER MISHANDLING. 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 THE FENESTRATED MARYLAND BIPOLAR INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. 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 FENESTRATED MARYLAND BIPOLAR INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 0801241 808

    Patients

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