BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1232777 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01383
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND ONE CONDUCTOR WIRE BROKEN AT THE YAW PULLEY EXIT. THE YAW PULLEY IS MISSING A .150" BY .060" PIECE OPPOSITE THE CONDUCTOR BREAK. THE INSTRUMENT HAS A BROKEN SECTION OF YAW PULLEY THAT CREATED A LARGE RANGE OF MOTION IN YAW FOR ONE GRIP. THE ADDED RANGE OF MOTION MOST LIKELY CREATED EXCESS TENSION ON THE WIRE, CAUSING IT TO BREAK. THE WIRE WAS MOST LIKELY NOT SECURELY ATTACHED TO THE GRIP, WITH POOR STRAIN RELIEF, RESULTING IN BREAKING DURING ARTICULATION OF THE WRIST. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A 1.75" LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THERE ARE ALSO A COUPLE OF DEEP SCRATCHES WITH LIGHT MATERIAL REMOVED. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A COMBINATION OF INSTRUMENT COLLISIONS AND 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. 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 TOTAL HYSTERECTOMY SURGICAL PROCEDURE THE PK DISSECTING FORCEPS INSTRUMENT DID NOT REACT TO A MOVEMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. 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 PK DISSECTING FORCEPS INSTRUMENT ELETROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 0711141 794

    Patients

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