BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20606170 · Received November 5, 2024

    Report

    Report Number
    2955842-2024-21392
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED PROBLEM WITH THE ERBE GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. 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 AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT HAD A BURN/RECTAL INJURY. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY AND PER AN OR NURSE FROM THE SITE, NO ARCING WAS OBSERVED DURING THE CASE. ON POST-OPERATIVE DAY #8, THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON POST-OPERATIVE DAY #9, THE PATIENT HAD AN X-RAY OF THE ABDOMEN SHOWING SMALL AMOUNTS OF FREE AIR. A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED ON POST-OPERATIVE DAY #9 AND EVENTUALLY CONVERTED TO OPEN SURGERY WHEN BLOOD WAS FOUND IN THE ABDOMEN. DURING THE SECOND PROCEDURE A RECTAL INJURY WAS NOTED. IT IS UNKNOWN WHAT MEDICAL/SURGICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. THE CAUSE OF THE COMPLICATION IS ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727906 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES