BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9446999 · Received December 10, 2019

    Report

    Report Number
    2955842-2019-10954
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 14, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE TIP COVER ACCESSORY BE RETURNED FOR EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI DID RECEIVE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) THAT WAS USED IN THE PROCEDURE AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONCLUDED THAT THE CUSTOMER REPORTED ISSUE OF ARCING BETWEEN INSTRUMENT TIPS WAS NOT CONFIRMED OR REPRODUCED. THE UNIT WAS TESTED AND BOTH MONOPOLAR AND BIPOLAR INSTRUMENTS ENERGIZED AS EXPECTED. AT NO POINT OF THE TESTING WAS ANY ARCING OBSERVED. THE TECHNICAL SAFETY CHECK PASSED. THE UNIT WILL BE RESTOCKED AS THERE WAS NO PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON NOTED ARCING BETWEEN INSTRUMENTS WITH NO EVIDENCE OF MISUSE. ADDITIONAL INFORMATION CONFIRMED THAT THE REPORTED THERMAL BOWEL BURN EXPERIENCED BY THE PATIENT WAS SUPERFICIAL AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. AT THIS TIME THE ETIOLOGY OF THE BOWEL INJURY IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT SURGEON HAD OBSERVED ARCING BETWEEN INSTRUMENTS. ON 11/22/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT (AFTER SPEAKING WITH THE CONSOLE SURGEON DIRECTLY): ARCING WAS OBSERVED BETWEEN MONOPOLAR CURVED SCISSORS (MCS) AND FENESTRATED BIPOLAR FORCEPS INSTRUMENTS. THE PATIENT SUSTAINED A BOWEL BURN. THERE WAS NO UNPLANNED MEDICAL ACTION TAKEN AND BOTH PROCEDURES COMPLETED ROBOTICALLY. INSTRUMENTS, ACCESSORIES, AND THE CANNULA (PIN GAGE NOT USED) WERE INSPECTED PRIOR TO USE. NO EVIDENT VISIBLE DAMAGE. THE TIP COVER ACCESSORY WAS APPLIED TO THE MCS INSTRUMENT WITH AN INSTALLATION TOOL; ELECTROLUBE WAS NOT USED. THE SURGEON WAS DISSECTING TISSUE WHEN THE ISSUE OCCURRED. THE SURGEON IS NOT SURE WHAT CAUSED THE ARCING; THE INSTRUMENTS WERE AT LEAST 2 CM APART. THE INSTRUMENTS AND ACCESSORIES HAD BEEN IN USE FOR APPROXIMATELY 2HRS. AN ERBE VIO GENERATOR WAS IN USE WITH SETTINGS AT CUT: 2 AND COAG: 2. MONOPOLAR ENERGY WAS BEING ACTIVATED AT THE TIME OF THE ISSUE. THE INSTRUMENTS WERE NOT REMOVED PRIOR TO THE ARCING EVENT. THERE WERE NO INSTRUMENT COLLISIONS AND THE ENERGY CORDS WERE CONNECTED PROPERLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE PROCEDURE WAS RECORDED AND THE INSTRUMENTS ARE AVAILABLE FOR RETURN. ON 12/5/2019, ISI CONFIRMED THAT THE ARCING WITH SUPERFICIAL THERMAL BURN EVENT OCCURRED ON (B)(6) 2019 WITH CONSOLE SURGEON. THE PATIENT SUSTAINED A SUPERFICIAL THERMAL BURN THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION; NO SUTURE(S) OR RESECTION. THERE ARE NO REPORTS OF POST-OPERATIVE COMPLICATIONS OR HOSPITAL RE-ADMISSION(S). THERE WAS NO ISI REPRESENTATIVE PRESENT DURING THE CASE. ON 12/9/2019, ISI CONFIRMED THAT THE CUSTOMER IS STILL TRYING TO FIND THE INSTRUMENTS AND TIP COVER ACCESSORY BUT HAVE BEEN UNABLE TO LOCATE THEM; THE CUSTOMER IS NOT HOPEFUL THAT THEY WOULD BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS RECORDED, THEY ARE TRYING TO FIND OUT HOW TO GET A COPY TO ISI. THE PROCEDURE WAS EITHER A CYSTECTOMY OR A PROSTATECTOMY. ISI FIELD SERVICE ENGINEER (FSE) INVESTIGATION HAS BEEN COMPLETED. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR CUSTOMER SATISFACTION. AT THE TIME OF THE REPLACEMENT, ERROR 54 WAS FOUND IN THE SYSTEM LOGS; DIRTY FIBER CABLE. THE FSE ISOLATED A DAMAGED FIBER CABLE AND DROP SHIPPED A REPLACEMENT FIBER CABLE TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240906 DAVINCI XI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180

    Patients

    Seq Age Sex Outcome Treatment
    1