BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 4783520 · Received May 19, 2015

    Report

    Report Number
    2955842-2015-00765
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K140189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE VESSEL SEALER INSTRUMENT STOPPED WORKING AND THERE WAS NO SEALING SOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, COULD NOT HEAR THE SEAL SOUND WHILE USING THE VESSEL SEALER INSTRUMENT TO SEAL. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. THERE WERE NO REPORTS OF ANY FRAGMENT(S) FALLING INTO THE PATIENT. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) OBTAINED FOLLOWING INFORMATION FROM ISI CLINICAL SALES REPRESENTATIVE (CSR): THE VESSEL SEALER INSTRUMENT WORKED AT THE BEGINNING FOR ABOUT 20-30 MINUTES AND THEN IT STOPPED WORKING. THE SURGEON PRESSED THE ENERGY ACTIVATION PEDAL AND THERE WAS NO SOUND FROM THE GENERATOR. THERE WAS NO ENERGY. ACCORDING TO THE CSR, THERE WERE NO ERROR MESSAGES GENERATED FROM THE SYSTEM OR THE GENERATOR. SURGEON DID NOT USE THE CUT FUNCTION AFTER KNOWING THAT THE VESSEL SEALER INSTRUMENT STOPPED WORKING. A NEW VESSEL SEALER WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER COMPLETION OF THE PROCEDURE, THE CSR RE-INSERTED THE INITIAL VESSEL SEALER INSTRUMENT AND IT DID NOT WORK. HE PRESSED THE FOOT PEDAL, BUT THERE WAS NO SOUND FROM THE GENERATOR AND NO ERROR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326706 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 480322-05 S10150330-0148

    Patients

    Seq Age Sex Outcome Treatment
    1