BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1052762 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01033
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND NONE OF THE CABLES OR WIRES ARE BROKEN, HOWEVER, ONE GRIP CLOSE CABLE IS FRAYED NEAR THE DISTAL IDLERS. THE GRIPS CAN STILL OPEN AND CLOSE. THE CABLE MAY HAVE BEEN NICKED BY ANOTHER INSTRUMENT, CAUSING THE BREAKAGE. ENGINEERING ALSO OBSERVED THAT THE DISTAL END OF MAIN TUBE HAS A 5 INCH LONG SECTION DIRECTLY ABOVE THE PROXIMAL CLEVIS WITH LIGHT MATERIAL REMOVED ALL AROUND THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PK DISSECTING FORCEPS INSTRUMENT HAS A BROKEN WIRE. 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 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 0712181 798

    Patients

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