BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22007762 · Received May 13, 2025

    Report

    Report Number
    2955842-2025-20244
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K162973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY MECHANICALLY REMOVING THE INSTRUMENT FROM THE ARM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) AFTER THE PROCEDURE THAT THEY CANNOT GET THE SUCTION IRRIGATOR OFF OF UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 3. TSE REVIEWED THE LOGS AND FOUND NO ERRORS. TSE ASSISTED THE CUSTOMER TO MANUALLY REMOVE THE SUCTION IRRIGATOR FROM THE ARM. THE CUSTOMER STATED THAT THE INSTRUMENT BROKE AND THE TIP WOULD NOT STRAIGHTEN UP TO GET OUT OF THE CANNULA. THE CUSTOMER REMOVED THE CANNULA AND INSTRUMENT FROM THE PATIENT AND WORKED ON GETTING IT REMOVED ON THE SIDE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: YES THE SUCTION IRRIGATOR WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. NO FRAGMENTS FELL. THE ACCESSORY WAS USED 30-45 MINS. THE SURGEON DID NOT NOTICE PRIOR TO THE EVENT. THE ACCESSORY WAS UNABLE TO SEPARATE FROM THE CANNULA WITHOUT CUTTING THE END OF THE IRRIGATOR PER INTUITIVE RECOMMENDATION. NO THE CANNULA AND IRRIGATOR CAME OUT TOGETHER AND THE IRRIGATOR END STILL BENT AND UNABLE TO REMOVE FROM THE TROCAR AND HAD TO CUT THE END PER RECOMMENDATION IN ORDER TO SAVE THE CANNULA IRRIGATOR NOT USEABLE AFTER THAT. YES, THE SURGICAL STAFF FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO, THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE STAFF HAD TO MANUALLY CUT THE END TO SEPARATE FROM THE TROCAR BECAUSE THE TIP WAS BENT. THE ACCESSORY WAS CUT OUTSIDE THE PATIENT¿S BODY. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE AND THE PROCEDURE WAS ROBOTICALLY COMPLETED. NO PATIENT INJURY OR HARM WAS DONE. NO, THE PATIENT DID NOT RETURN TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181492 ENDOWRIST SUCTION IRRIGATOR NAY INTUITIVE SURGICAL, INC 480299-06 K10240829 0403

    Patients

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