BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1133566 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01234
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THAT THE DISTAL END OF THE MAIN TUBE HAS A COUPLE OF SECTIONS WITH MATERIAL REMOVED ON ONE SIDE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGEON SAW SHAVINGS FROM THE SHAFT OF THE PK DISSECTING FORCEPS INSTRUMENT FALL INTO THE PT. THE SURGEON IMMEDIATELY REMOVED THE PK DISSECTING FORCEPS INSTRUMENT, IRRIGATED THE AREA, AND REMOVED ALL VISIBLE SHAVING FROM THE PT'S ANATOMY. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A DIFFERENT INSTRUMENT. 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 ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 0803201 913

    Patients

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