BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3935243 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04275
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. FUNCTIONAL PERFORMANCE TESTING DID NOT FIND ANY ISSUES. THE INSTRUMENT WAS INSTALLED ON INSTRUMENT PERFORMANCE TESTER(IPT) FOR AN ADDITIONAL FUNCTIONAL CHECK, AND THE INSTRUMENT WAS FULLY FUNCTIONAL. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE ALONG THE FIRST 3.00 OF THE MAINTUBE CLOSEST TO THE CLEVIS AND WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER WAS DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD A BROKEN CABLE. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE USER FACILITY TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT BUT WAS NOT ABLE TO OBTAIN ANY DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414012 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120806 772

    Patients

    Seq Age Sex Outcome Treatment
    1