BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 1061789 · Received June 13, 2008

    Report

    Report Number
    2955842-2008-01074
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    June 16, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTING AND FOUND THE INSTRUMENT TO MOVE INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS WITH THE GRIPS OPENING AND CLOSING PROPERLY. ENGINEERING ALSO FOUND THE DISTAL END OF THE MAIN TUBE TO HAVE A SECTIONS, 180 DEGREES APART, WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREAS ARE 2" AND 2.5" LONG, PARALLEL TO TUBE AXIS AND HAVE A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. NO OTHER DAMAGE WAS FOUND. A FOLLOW-UP MDR WILL BE SUBMITTED FI ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CADIERE FORCEPS INSTRUMENT DID NOT WORK. 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 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 1010072 410

    Patients

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