BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14682126 · Received June 13, 2022

    Report

    Report Number
    2955842-2022-12156
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 16, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE WAS ABLE TO CONFIRM THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE REPLACED MTM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPRODUCED THE REPORTED COMPLAINT. THE REPORTED FAILURE WAS REPRODUCED DURING CALIBRATION VIA TESTING. INVESTIGATION IDENTIFIED COMPONENT FAILURE AND REPLACEMENT OF THE GRIP LEVER, INNER GRIP SPRING, OUTER GRIP SPRING WERE PERFORMED TO RESOLVE THE ISSUE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE AND ISI FSE'S INVESTIGATION THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE MTM WAS NOT FUNCTIONING PROPERLY AFTER THE START OF THE PROCEDURE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS ON UNIVERSAL SIDE MANIPULATOR (USM) ARMS 1 AND 2 WOULD NOT CLOSE. PRIOR TO CALLING TECHNICAL SUPPORT, THE SITE RESTARTED THE SYSTEM; HOWEVER, THE PROBLEM PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THEY RESEAT THE STERILE ADAPTER AND CHECK THAT THE DISKS WERE SPINNING, BUT THIS HAD NO EFFECT. THE INSTRUMENT WORKED NORMALLY IN USM ARM 4. THE SURGEON MENTIONED THAT THE LEFT MASTER TOOL MANIPULATOR (MTM), WHICH WAS CONTROLLING USM ARMS 1 AND 2, WAS MAKING A STRANGE NOISE. TSE REVIEWED THE LOGS AND DID NOT FIND ANY ISSUES. THE SURGEON STATED THEY COULD END SURGERY WITHOUT THE DA VINCI SYSTEM AND NO IMPACT TO THE PATIENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. NO PATIENT INFORMATION WAS AVAILABLE. THE ISSUE OCCURRED AT THE END OF SURGERY. THEY WERE ABLE TO PROCEED WITH THE DA VINCI SYSTEM. THE LARGE BOWEL ANASTOMOSIS WAS PERFORMED BY THE TIME OF THE ISSUE AND THEY WERE IN THE FINAL OBSERVATION OF THE ANATOMY PART. THE SURGEON WAS ABLE TO FINISH THE PROCEDURE WITH THE RIGHT HAND (RIGHT MTM ARM), BECAUSE ALL THE SURGICAL MOVEMENTS WERE FINISHED AND THEY WERE GOING TO UNDOCK THE PATIENT SIDE CART IN A FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688807 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-21 N/A 00886874110744

    Patients

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