BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1203502 · Received October 17, 2008

    Report

    Report Number
    2955842-2008-01324
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING DISCOVERED A BROKEN CONDUCTOR WIRE AT THE YAW PULLEY EXIT. THE YAW PULLEY IS MISSING A .150" X .060" PIECE OPPOSITE OF THE CONDUCTOR BREAK, ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION. IT CANNOT BE DETERMINED HOW THE YAW PULLEY BROKE, HOWEVER, THE ADDED RANGE OF GRIP MOTION LIKELY CREATED EXCESS TENSION ON THE WIRE AND CAUSED IT TO BREAK. ENGINEERING EVALUATION ALSO OBSERVED A 1.75" LONG SECTION WITH LIGHT MATERIAL REMOVED ON THE DISTAL END OF THE MAIN TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED. ADJACENT TO THE MAIN TUBE DAMAGED SECTION ARE DEEP SCRATCHES WITH MATERIAL REMOVED. 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 THE MARYLAND BIPOLAR FORCEPS INSTRUMENT DOES NOT WORK. NO ADDITIONAL INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 0711292 649

    Patients

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