BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER

    MDR report key: 7283860 · Received February 20, 2018

    Report

    Report Number
    2955842-2018-00105
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 26, 2018
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE. THE VESSEL SEALER WAS FOUND TO HAVE THE JAWS STUCK IN THE CLOSE POSITION. FURTHER INSPECTION OF THE INSTRUMENT FOUND HIGH FRICTION BETWEEN THE PLANETARY AND HELICAL GEARS WHEN ACTUATED IN COUNTER-CLOCKWISE/GRIP OPEN POSITION. ADDITIONALLY, THE CLAMPING GEAR WAS FOUND ROTATED 60 DEGREE IN CLOCK-WISE DIRECTIONS WHILE STILL CLAMPED TO DRIVE SHAFT, AND THE GRIP OPEN INPUT WAS DRIVEN TO THE HARD STOP KEY LOCATED ON CHASSIS. THIS SUGGESTS THAT THERE WAS LIKELY A GEAR SLIPPAGE THAT OCCURRED DURING USE. THE INSTRUMENT WAS DISSEMBLED TO INSPECT FOR DAMAGE OR MECHANICAL WEAR TO THE MENTIONED COMPONENTS, BUT NO SIGNIFICANT FINDINGS FOUND. THEREFORE, NO CAUSE COULD BE DETERMINED. IF NEW INFORMATION IS FOUND, THIS INVESTIGATION WILL BE RE-EVALUATED. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE INVOLVED WITH THE COMPLAINT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THERE IS NO EVIDENCE THAT THE ISI DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT THE ISI DEVICE MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT INVOLVED WITH THIS COMPLAINT, HOWEVER, THE DEVICE EVALUATION IS STILL IN PROGRESS AND HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO OPEN THE JAWS OF THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT. ALTHOUGH, NO PATIENT HARM WAS REPORTED AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE CUSTOMER REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO OPEN THE JAWS OF THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT. THE INSTRUMENT WAS REMOVED AND INSPECTED AND CONFIRMED THAT THE JAWS WOULD NOT OPEN. ANOTHER ENDOWRIST ONE VESSEL SEALER INSTRUMENT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126858 ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-05 M11170817

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR