BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3988956 · Received August 7, 2014

    Report

    Report Number
    2955842-2014-04808
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 9, 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 WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CABLE ON ONE SIDE OF DISTAL CLEVIS IS DERAILED FROM DISTAL IDLER PULLEY. THE YAW MOTION IS NON-INTUITIVE AS A RESULT. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .071 - .196 IN LENGTH AND ARE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION 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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT, IT WAS NOTED THAT THE CLAMP ON THE INSTRUMENT WOULD NOT CLOSE PROPERLY. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO THE PATIENT AND THERE WAS NO ALLEGATION OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464447 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M20120305 709

    Patients

    Seq Age Sex Outcome Treatment
    1