BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3135965 · Received May 29, 2013

    Report

    Report Number
    2955842-2013-01899
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 2, 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. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT, SHOWING 3 USES LEFT. THE POGO PINS WERE NOT STUCK AND WERE NOT CONTAMINATED. DCP VERIFICATION OF INSTRUMENT PASSED. ELECTRICAL CONTINUITY TEST PASSED. THE INSTRUMENT WAS DRIVEN AND MOVED INTUITIVELY AND GRIPS OPENED AND CLOSED. ADDITIONAL FINDINGS NOT REPORTED WERE SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; TUBE ABRASIONS WITH MATERIAL REMOVAL , 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 A DA VINCI SI SURGICAL PROCEDURE THE PRECISE BIPOLAR FORCEPS INSTRUMENT WAS WORKING AT THE BEGINNING OF THE SURGERY. THE SURGEON USED ANOTHER INSTRUMENT AND THEN WANTED TO REUSE THE PRECISE BIPOLAR FORCEPS, IT WAS NOT RECOGNIZED BY THE SYSTEM. THEY TRIED SOME MANIPULATIONS (REMOVE, REPLACE) BUT IT WAS STILL NOT RECOGNIZED. THERE WERE NO MISSING PIECES OR FALLEN PIECES 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
    234511 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10120221 620

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES ESU