BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 15863490 · Received November 24, 2022

    Report

    Report Number
    2955842-2022-15524
    Event Type
    Injury
    Date Received
    November 24, 2022
    Report Date
    October 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS NOT PERFORMED FOR THIS PROCEDURE: THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN UNSPECIFIED DA VINCI-ASSISTED COLORECTAL PROCEDURE, THE PATIENT HAD AN ALLERGIC REACTION TO THE MEDICAL DIAGNOSTIC DYE (I.E. ICG) AND WENT INTO ANAPHYLACTIC SHOCK, REQUIRING INTRA-OPERATIVE INTERVENTION. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED COLORECTAL PROCEDURE, THE PATIENT HAD AN ALLERGIC REACTION TO THE MEDICAL DIAGNOSTIC DYE INDOCYANINE GREEN (ICG) AND WENT INTO ANAPHYLACTIC SHOCK, REQUIRING INTRA-OPERATIVE INTERVENTION. DETAILS REGARDING THE MEDICAL INTERVENTION RENDERED WERE NOT PROVIDED. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE SURGEON TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706875 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-13 N/A 00886874110690

    Patients

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