BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14366188 · Received May 11, 2022

    Report

    Report Number
    2955842-2022-11563
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 11, 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
    CA, US
    Reporter Occupation
    003

    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 FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE SUBJECTED THE UNIVERSAL SURGICAL MANIPULATOR ARMS INTO MULTIPLE TESTING AND PASSED WITH NO ERRORS. ALL THE USM ARMS PASSED TESTING SPECIFICATION. THE SYSTEM OPERATED WITHOUT ISSUE AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE'S INVESTIGATION. NO IMAGE/VIDEO INVESTIGATION REQUIRED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO RESISTANCE ON ARM1 AND ARM3. 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 PROCEDURE CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) THAT THE CUSTOMER EXPERIENCED RESISTANCE ON UNIVERSAL SIDE MANIPULATOR (USM) ARMS 1 & 3 DURING A DA VINCI-ASSISTED INCISIONAL HERNIA IPOM SURGICAL PROCEDURE AND THE SURGEON ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THAT THE INFORMATION WAS OBTAINED AFTER THE FACT. THE CTA STATED THAT THE SURGEON FELT THAT THERE WAS SIGNIFICANT RESISTANCE WHEN INSERTING THE INSTRUMENTS INTO ARMS 1 AND 3. TROUBLESHOOTING WAS ATTEMPTED BY RESEATING THE STERILE ADAPTER; HOWEVER, CUSTOMER DID NOT CHANGE OUT THE DRAPE AS PART OF THE TROUBLESHOOTING. THE CTA WAS UNABLE TO PROVIDE FURTHER INFORMATION. TSE'S REVIEW OF THE SYSTEM LOGS FOUND A FEW MINOR ERRORS RELATED TO THE ARMS. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. 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
    2311551 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 00886874110720

    Patients

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