BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 7557395 · Received May 31, 2018

    Report

    Report Number
    2955842-2018-10244
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 10, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT, HOWEVER, AN INCOMPLETE FAILURE ANALYSIS WAS PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT. THE CUSTOMER AUTOCLAVED THE INSTRUMENT AND THEREFORE AN ENERGY ACTIVATION TEST COULD NOT BE PERFORMED. ADDITIONAL TESTING SUCH AS GRIP FORCE AND JAW GAP INSPECTION COULD NOT BE PERFORMED AS WELL. HOWEVER, VISUAL INSPECTION OF THE INSTRUMENT DID FIND A DISLODGED BLADE EXPOSED OUTSIDE OF THE BLADE GARAGE. NO CONDUCTOR WIRE DAMAGE OR SNAKE WRIST DAMAGE WAS FOUND. THERE WAS SIGNIFICANT BIO DEBRIS FOUND AT THE INSTRUMENT TIP. A REVIEW OF THE INSTRUMENT LOGS FOUND 1 BLADE EXPOSED FAILURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE VESSEL SEALER INSTRUMENT STOPPED SEALING. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, RECURRENCE OF THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT STOPPED SEALING. THE VESSEL SEALER INSTRUMENT WAS ABLE TO SUCCESSFULLY COMPLETE A SEAL PRIOR TO THIS REPORTED ISSUE. THE SYSTEM DID NOT GENERATE AN ERROR MESSAGE AND APPROPRIATE AUDIBLE TONES FOR THE SEALING CYCLE/COMPLETION OF SEALING WERE GENERATED. THE SURGEON WAS ABLE TO SEE TISSUE CAUTERIZING. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 10-MAY-2018, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, AS OF THE DATE OF THIS REPORT NO ADDITIONAL DETAILS HAVE BEEN OBTAINED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398971 ENDOWRIST;DAVINCI SI VESSEL SEALER NAY INTUITIVE SURGICAL, INC 410322-05 M11171013

    Patients

    Seq Age Sex Outcome Treatment
    1