BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14660739 · Received June 10, 2022

    Report

    Report Number
    2955842-2022-12103
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 13, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) CONTACTED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE INVESTIGATION WITH THE OPERATING ROOM MANAGER, REVIEW OF THE SYSTEM LOGS AND CONFIRMATION OF CURRENT SYSTEM PERFORMANCE CONCLUDED THAT AT THE TIME OF THE EVENT A HOSPITAL PERSONNEL PRESSED THE POWER BUTTON, CAUSING THE SYSTEM TO (INADVERTENTLY) SHUT DOWN. FSE FURTHER CONFIRMED THAT NO ISSUES WERE NOTED ON THE SUBSEQUENT CASES THAT THE SAME SYSTEM WAS USED ON. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT 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 13-MAY-2022 ON SYSTEM SH1507 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: THE CUSTOMER CONVERTED TO A LAPAROSCOPIC PROCEDURE AFTER THE START OF THE PROCEDURE DUE TO SYSTEM SHUTTING DOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO-OOPHORECTOMY SURGICAL PROCEDURE THAT THE SYSTEM SHUT OFF DURING THE PROCEDURE. AFTER THE SYSTEM POWERED OFF, THE CUSTOMER POWERED THE SYSTEM ON FROM THE VISION SIDE CART (VSC). AFTER THE SYSTEM POWERED ON, THE SYSTEM POWERED OFF AGAIN. THE STAFF POWERED THE SYSTEM ON A SECOND TIME FROM THE VSC AND THE SYSTEM THEN STAYED ON. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). PRIOR TO CALLING FOR SUPPORT, THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC TO COMPLETE THE PROCEDURE AS THEY WERE UNCERTAIN OF WHAT CAUSED THE SYSTEM TO POWER OFF. UPON REVIEW, TSE INDICATED THAT THE ONSITE LOGS SHOWED THAT THE POWER OFF WAS INITIATED FROM SURGEON SIDE CONSOLE 1 (SSC1), FOLLOWED BY A POWER ON REQUEST FROM THE VSC. THE LOGS ALSO SHOWED THAT AFTER THE SYSTEM WAS POWERED ON FROM THE VSC, THE SAME VSC POWER BUTTON WAS DEPRESSED POWERING THE SYSTEM BACK OFF. ADDITIONALLY THE LOGS SHOWED THAT A SHORT TIME LATER THE SYSTEM WAS POWERED BACK ON FROM THE VSC AND ULTIMATELY STAYED POWERED ON. THE LAPAROSCOPIC PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT 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
    2218149 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A 00886874110874

    Patients

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