BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15071034 · Received July 20, 2022

    Report

    Report Number
    2955842-2022-13064
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 21, 2022
    Report Date
    June 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. THE REPORT SUBMITTED UNDER PATIENT IDENTIFIER (B)(6) DOCUMENTS THE INITIAL OCCURRENCE OF THE ISSUE ON (B)(6) 2022 INCLUDING THE FIELD SERVICE ENGINEER (FSE) INVESTIGATION AND SUBSEQUENT INTEGRATED ELECTROSURGICAL UNIT ERBE (ERBE) GENERATOR REPLACEMENT, WHILE THE REPORT UNDER PATIENT IDENTIFIER (B)(6) (THIS RECORD) DOCUMENTS THE RECURRENCE OF THE ISSUE DURING A SUBSEQUENT PROCEDURE ON (B)(6) 2022. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SK0280 MATCHING THE DOCUMENTED EVENT DETAILS. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THE FSE INVESTIGATED THE REPORTED COMPLAINT. THE ERBE WAS REPLACED TO CORRECT THE CUSTOMER REPORTED PROBLEM. AFTER REPLACEMENT, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ERBE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPRODUCED THE REPORTED COMPLAINT. THE UNIT WAS RETURNED FOR ERROR C-33. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE ERROR CODE WAS NOT DISPLAYED ON THE UNIT WHEN POWERING IT UP; HOWEVER, THE ERROR CODE WAS CONFIRMED WHEN VIEWING THE ERROR LOGS. THE VISUAL INSPECTION SHOWED ERBE WAS IN GOOD CONDITION. THE UNIT WILL BE RETURNED TO OEM FOR REPAIR. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE INTEGRATED ELECTROSURGICAL UNIT ERBE (ERBE) WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP THIRD-PARTY ESU. 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. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT AN ERROR C-00 REOCCURRED EACH TIME THE INTEGRATED ELECTROSURGICAL UNIT ERBE (ERBE) WAS POWERED ON. THE SYSTEM LOGS CONFIRM ERBE ERROR C-33, INDICATING AN INTERNAL VOLTAGE ERROR. THE CUSTOMER CONTINUED THE PROCEDURE USING A FORCE TRIAD ALTERNATE GENERATOR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON RESPONDED THAT THERE WAS NO INJURY/HARM TO THE PATIENT. THE ISSUE WAS RESOLVED BY USING A BACKUP GENERATOR. THERE WAS A PROCEDURE DELAY OF 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718654 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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