BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 8138199 · Received December 6, 2018

    Report

    Report Number
    2955842-2018-10718
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND THE SYSTEM WAS TESTED. IT WAS REPORTED THAT THE FSE COULD NOT REPRODUCE THE ISSUE AND THE SYSTEM WAS FUNCTIONING WELL WITH NO TROUBLE FOUND. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE USER MANUAL DOES STATE THE FOLLOWING WARNING: "MAKE SURE THAT THE INSTRUMENT MOVES SMOOTHLY IN AND OUT OF THE CANNULA. USE CAUTION AND VIEW THE INSTRUMENT TIP WITH THE ENDOSCOPE WHEN MANUALLY INSERTING AN INSTRUMENT INTO THE PATIENT." THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT'S LIVER WAS NICKED AND THE SURGEON HAD TO CAUTERIZE IT. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INJURY REPORTED IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, ARM 4 OF THE PATIENT SIDE CART (PSC) MOVED ERRATICALLY AND MADE CRACKLING NOISES. AFTER INSERTING AN INSTRUMENT, THE ARM JERKED FORWARD ERRATICALLY AND NICKED THE LIVER. THE CUSTOMER WAS ABLE TO REPAIR THE INJURY. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: DURING PROCEDURE WHILE THE NURSE WAS DOING A GUIDED TOOL CHANGE BY REMOVING THE PERMANENT CAUTERY HOOK INSTRUMENT AND INSERTING A CLIP APPLIER INSTRUMENT, THE NURSE HEARD A GRINDING NOISE ON THE INSTRUMENT CLUTCH LOCATION ON ARM 4. AS THE INSTRUMENT WAS INSERTED IT JERKED FORWARD AND NICKED THE LIVER. SHE REPORTED THAT THE NICK WAS VERY TINY AND THE SURGEON CAUTERIZED IT WITH THE PERMANENT CAUTERY HOOK INSTRUMENT. THE NURSE CONFIRMED THAT THIS JERKY MOVEMENT DURING THE PROCEDURE HAPPENED JUST ONE TIME WITH THE CLIP APPLIER INSTRUMENT AND NOT NOTICED WITH ANY OTHER INSTRUMENT. SHE ALSO STATED THAT THEY CONTINUED USING THE SAME INSTRUMENT THROUGHOUT THE SURGERY AND HAD NO FURTHER ISSUES DURING INSERTION OR REMOVAL. THE NURSE CONFIRMED THERE WERE NO SYSTEM ERRORS GENERATED AT THAT TIME. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. AN ISI FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND THE SYSTEM WAS TESTED. IT WAS REPORTED THAT THE FSE COULD NOT REPRODUCE THE ISSUE AND THE SYSTEM WAS FUNCTIONING WELL WITH NO TROUBLE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977212 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI INSTRUMENTS AND ACCESSORIES