BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14941755 · Received July 7, 2022

    Report

    Report Number
    2955842-2022-12812
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE POWERED ON THE SYSTEM WITH ERROR 23007 POINTING TO PATIENT SIDE MANIPULATOR (PSM) 3 AXIS 3. THE 23007 ERROR WOULD NOT RECOVER, AND PSM 3 FAILED ITS POWER ON SELF-TEST. THE FSE NOTED THAT PSM 3 INSERTION AXIS 3 COULD MOVE MANUALLY BUT VERY HARD. THE FSE SWAPPED PSM 3 WITH PSM 1, AND THE ISSUE WOULD FOLLOW TO PSM 1. THE FSE DETERMINED THAT THE ISSUE WAS RELATED TO PSM 3. THE FSE REPLACED THE PSM TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE PSM FOR EVALUATION, BUT THE PRODUCT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR ANALYSIS AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: A PSM WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING THE OTHER ARMS. SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. PRODUCT EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT SIDE MANIPULATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPRODUCE THE REPORTED FAILURE (ERROR 23007 ALONG INSERTION / AXIS 3) DURING SYSTEM POWER-UP. THE AXIS 3 BRAKE WOULD BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE ROOT CAUSE WAS DETERMINED TO BE A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT AFTER SWAPPING AN INSTRUMENT ON PATIENT SIDE MANIPULATOR (PSM) 3, THE PSM INSERTION WOULD NOT MOVE. THERE WAS NO ERROR MESSAGE AT THE TIME OF THE EVENT, AND THE LIGHT EMITTING DIODES (LEDS) WERE NORMAL. THE CUSTOMER HAD RESTARTED THE SYSTEM, REINSTALLED THE INSTRUMENT, AND RE-DRAPED PSM 3 WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED WITH THE CUSTOMER THAT THE INSTRUMENT ARM DRAPE WAS NOT STUCK INSIDE THE RAIL, THE STERILE ADAPTOR DISC ENGAGEMENT HAD NO ISSUE, AND THE CLUTCH BUTTON WAS WORKING FINE. THE SITE CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS REPORTEDLY CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. PSM 3 HAD AN ERROR DURING THE PROCEDURE, AND THE SITE COULD NOT DISABLE THE PSM. THE SITE ELECTED TO MOVE PSM 3 ASIDE AND CONTINUED WITH THE REMAINING PSMS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046991 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-12 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES