BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 18862551 · Received March 7, 2024

    Report

    Report Number
    2955842-2024-12191
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 23, 2024
    Report Date
    February 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE INITIAL REPORTER AND WAS INFORMED THAT THE SURGEON HAD REPORTED HAVING TO MATCH GRIPS MULTIPLE TIMES DURING ONE OF HIS CASES. THERE WERE NO ERRORS ON THE SYSTEM, AND THE SAME SURGEON HAS SINCE PERFORMED MULTIPLE CASES USING THE SAME SSC. THE SYSTEM OPERATED AS EXPECTED AND WITH NO ISSUES. THE REPORTED ISSUE COULD NOT BE REPRODUCED. SYSTEM TESTED AND VERIFIED AS READY FOR USE. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE HAND CONTROLS ON SURGEON SIDE CONSOLE (SSC) 1 WERE STICKING. THE CUSTOMER EXPLAINED THAT THE SURGEON HAD TO KEEP MATCHING GRIPS TO REGAIN CONTROL OF THE INSTRUMENTS. THE CUSTOMER ALSO STATED THAT THE ISSUE WAS ISOLATED TO SSC 1 AND THAT SSC 2 DID NOT HAVE THE SAME ISSUE. AN INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND FOUND NO RELATED ERRORS. THE TSE HAD THE CUSTOMER CHECK CONSOLE ARMREST; CUSTOMER CONFIRMED THE ARMREST WAS SECURE AND NOT LOOSE. THE TSE ALSO CONFIRMED THAT THE SURGEON WAS NOT REMOVING HIS HEAD FROM THE STEREO VIEWER, CAUSING THEM TO HAVE TO MATCH GRIPS TO REGAIN CONTROL OF INSTRUMENTS/ARMS. THE CUSTOMER WAS CONTINUING WITH THE PROCEDURE AS PLANNED AND WOULD USE THE SECOND SSC. THE PROCEDURE WAS COMPLETED WITH NO INDICATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195829 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-06 N/A 00886874115374

    Patients

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