BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17056224 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15638
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ERBE WAS FAULTING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED PN: 951300-03 ERBE GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED BUT REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT WAS ENERGIZED, CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE GENERATOR (ERBE) WAS FAULTING. THE BIPOLAR WOULD NOT WORK. OPERATING ROOM (OR) STAFF STATED THE SURGEON USED VESSEL SEALER EXTEND (VSE) INSTRUMENT CONNECTED TO NEW GENERATOR (E-100) TO COMPLETE THE CASE ROBOTICALLY. INTUITIVE SURGICAL INC.(ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERROR C-34 AND M-11 IN ONSITE LOGS. THE PROCEDURE WAS COMPLETED 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
    1488175 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES