BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    MDR report key: 3964064 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04587
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING OF THE DOUBLE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, IT WAS DISCOVERED THAT THE CABLE AT THE END OF THE INSTRUMENT WAS FRAYED. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT BROKE OFF AND FELL INTO A PATIENT AND THERE WAS NO ALLEGATION OF ANY PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442127 DOUBLE FENESTRATED GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420189-07 M10100915 323

    Patients

    Seq Age Sex Outcome Treatment
    1