BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1041287 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00258
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE DISTAL END OF MAIN TUBE HAS A 5.5 INCH LONG SECTION WITH MATERIAL REMOVED ALL AROUND THE TUBE. DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSE BY A CANNULA ACCESSORY. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED. ENGINEERING ALSO OBSERVED THAT ONE GRIP CLOSE CABLE IS DERAILED AT THE DISTAL IDLERS. NO OTHER DAMGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOWRIST PROGRASP FORCEPS INSTRUMENT HAD EXCESSIVE WEAR OF THE SHAFT, AND NO PIECES FELL INTO THE PT. NO ADD'L INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 0711261 558

    Patients

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