BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 5088534 · Received September 18, 2015

    Report

    Report Number
    2955842-2015-01219
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 28, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO CONFIRM THE ALLEGED SEALING ISSUE. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE ELECTRODE GAP TEST WAS PERFORMED AND IT PASSED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A PROCEDURE, WHILE USING THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT, ALLEGEDLY, THE INSTRUMENT WAS NOT CAUTERIZING THE PATIENT'S TISSUE. IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, IT WAS OBSERVED THAT THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT WAS NOT CAUTERIZING. THE SURGEON WAS ABLE TO HEAR AUDIBLE SEAL SOUND HOWEVER THE END BEEP WAS NOT HEARD. ON SEPTEMBER 02, 2015, INTUITIVE SURGICAL INC., (ISI) OBTAINED THE FOLLOWING INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT DID WORK HOWEVER, THERE WERE NO ALARMS OR ERROR MESSAGES TO INDICATE THAT THE INSTRUMENT WAS NOT SEALING. THE VESSELS WERE NOT HIGHLY CALCIFIED OR IN EXCESS OF 7MM IN DIAMETER. THE SURGEON WAS HOLDING DOWN THE MASTER GRIPS FULLY CLOSED THROUGHOUT THE SEALING CYCLE. THE SURGEON DID NOT HEAR THE TWO AUDIBLE HIGH PITCH TONES SIGNALING THAT THE GENERATOR HAS AUTOMATICALLY STOPPED APPLYING ENERGY. NO TISSUE EFFECT WAS OBSERVED. THE SYSTEM DID NOT GIVE ANY ERRORS OR MESSAGE THAT THE VESSEL SEALER WAS NOT COAGULATING OR SEALING. THE SURGEON DID NOT ATTEMPT TO USE THE CUT FUNCTION AFTER ATTEMPTING TO SEAL. THERE WAS NO BLEEDING OBSERVED. THERE WAS NO ALLEGATION THAT ANY FRAGMENT(S) FROM THE INSTRUMENT FELL INTO THE PATIENT AND/OR THAT ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620431 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-05 M10150430 184

    Patients

    Seq Age Sex Outcome Treatment
    1