BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18020124 · Received October 27, 2023

    Report

    Report Number
    2955842-2023-19678
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATION CANNOT BE DETERMINED. THIS PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, NO RELATED SYSTEM ERRORS 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. 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 BY THE DA VINCI COORDINATOR FOR THE SITE THAT 15 DAYS AFTER A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH INTERMITTENT FEVER, GENERAL WEAKNESS, CHILLS, DIAPHORESIS, AND LIGHTHEADEDNESS. ALTHOUGH AN INFECTION WAS NOT CONFIRMED AND THERE WERE NO FINDINGS REGARDING THE CAUSE OF THE FEVER, THE PATIENT WAS TREATED WITH THE BROAD-SPECTRUM ANTIBIOTIC BACTRIM. A BLOOD CULTURE WAS NOT TAKEN WHEN THE PATIENT PRESENTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED IN STABLE CONDITION TWO DAYS LATER. PER THE DISCHARGE REPORT FOR THE PATIENT, FLOMAX CAN CAUSE DIZZINESS. WHEN ASKED IF THE PATIENT EXPERIENCED ANY OTHER POSTOPERATIVE COMPLICATIONS, THERE WAS NO RESPONSE. WHEN ASKED IF ANY OTHER MEDICAL TREATMENTS WERE ADMINISTERED, THERE WAS NO RESPONSE. WHEN ASKED IF OTHER SURGEONS AT THE SITE ENCOUNTERED POST-OPERATIVE INFECTIONS, IF THE INFECTIONS HAVE BEEN LIMITED TO DA VINCI-ASSISTED PROCEDURES OR IF THEY HAVE OCCURRED WITH LAPAROSCOPIC AND/OR OPEN SURGERIES, AND IF THE SITE'S INSTRUMENT CLEANING OR STERILIZATION METHODS, THERE WAS NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047311 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES