BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3800481 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02854
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT OF THE INSTRUMENT NOT FUNCTIONING. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM, AND THE INSTRUMENT WAS SUCCESSFULLY RECOGNIZED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS INSTRUMENT WAS RECOGNIZED BY THE SYSTEM, BUT DID NOT FUNCTION. THE ENERGY CABLE WAS EXCHANGED, BUT THE INSTRUMENT STILL DID NOT FUNCTION. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277926 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10130711 476

    Patients

    Seq Age Sex Outcome Treatment
    1