BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3392491 · Received October 7, 2013

    Report

    Report Number
    2955842-2013-04096
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    July 23, 2013
    Report Date
    September 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION DID NOT CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT INSTALLED ON AN IN-HOUSE IS3000 SYSTEM PASSED INTUITIVE MOTION TESTING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .050 - .150 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. IT WAS CONCLUDED THAT THE DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS, HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE, FOUND DURING FAILURE ANALYSIS INVESTIGATION 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 A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO CONTROL THE ARTICULATION OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT. REPORTEDLY, THIS OCCURRED 4 TIMES WHILE THE INSTRUMENT WAS IN USE. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    507346 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10121214 839

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR DA VINCI SI SURG SYS INSTRMNTS, ACCESSORIES & ESU