BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 1052757 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01025
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS ALLOWING THE PULLEY TO SPIN FREELY. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. ENGINEERING CONCLUDED THE CABLE BROKE UNDER TENSILE LOADING AND THAT THE CABLE WEAR ON PULLEYS COMBINED WITH THE HIGH GRASPING FORCE MOST LIKELY CONTRIBUTED TO THE BREAKAGE. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS A 2 INCH LONG SECTION DIRECTLY ABOVE THE PROXIMAL CLEVIS WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED IS PARALLEL TO THE TUBE AXIS WITH A ROUGHER SURFACE FINISH THAN THE REST OF THE TUBE. 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 INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WIRES WERE COMING OUT OF THE TENACULUM FORCEPS INSTRUMENT. 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 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420207-04 2609071 738

    Patients

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