BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14517378 · Received May 26, 2022

    Report

    Report Number
    2955842-2022-11810
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 26, 2022
    Report Date
    April 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED ISSUE COULD NOT BE REPLICATED DURING FIELD EVALUATION. FSE TESTED THE SYSTEM AND CONFIRMED NO ISSUE WITH ANY OF THE USM ARMS AND THE SYSTEM. AS A PREVENTIVE MEASURE, FSE PERFORMED ELECTRICAL AND MECHANICAL ADJUSTMENTS ON USM4. FOLLOWING THIS, SYSTEM TESTED AND VERIFIED AS READY FOR USE. 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 USING SYSTEM SK2511 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 BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT A UNIVERSAL SURGICAL MANIPULATOR (USM) MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ROBOTICS COORDINATOR (ROCO) CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT UNIVERSAL SURGICAL MANIPULATOR (USM4) MOVES UNITUITIVELY WHEN GRIPPING A VESSEL. USER STATED THAT THE ISSUE WITH USM4 HAPPENS INTERMITTENTLY. TSE VIEWED SYSTEM LOGS WITH NO ERRORS NOTED ON ANY OF THE USM ARMS OR THE SYSTEM. SURGEON PROCEEDED WITH THE CASE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711542 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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