BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14861240 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12571
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    November 23, 2021
    Report Date
    December 3, 2021
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. FAILURE ANALYSIS (FA) WAS NOT CONDUCTED AS THE DEVICE WAS NOT RETURNED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS SHOWED NO OBSERVED EVENTS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS EVENT WAS REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) PRINCIPAL TOXICOLOGIST. THE FOLLOWING ADDITIONAL INFORMATION AS PROVIDED: ISI CANNULAS ARE MADE WITH STAINLESS STEEL THAT CONTAINS NICKEL AS A CONSTITUENT OF THE STEEL ALLOY. THE SPECIFIC GRADE OF STEEL ALLOY HAS A VERY LOW NICKEL EXPOSURE CHARACTERISTICS IN A SURGICAL SETTING. HOWEVER, IF THE PATIENT IS ALREADY HYPERSENSITIVE TO NICKEL, THEN THERE IS A LOW RISK OF ALLERGIC REACTION FROM EXPOSURE TO THE CANNULA FOR THIS PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED VENTRAL HERNIA TAPP PROCEDURE, THE PATIENT HAD REDNESS AT THE CANNULA SITE. THE SURGEON SUSPECTED THE REDNESS WAS DUE TO AN ALLERGY REACTION, AS THE REDNESS OCCURRED ON THE SKIN SURROUNDING ALL FOUR (4) CANNULAS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED VENTRAL HERNIA TAPP PROCEDURE, THE PATIENT HAD REDNESS AT THE 8MM INSTRUMENT CANNULA SITE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 07-DEC-2021 AN INTUITIVE SURGICAL, INC. (ISI) EXECUTIVE SALES REPRESENTATIVE (ESR) WAS PROVIDED THE FOLLOWING INFORMATION FROM THE SURGEON: THE SURGEON SUSPECTED THE REDNESS WAS DUE TO AN ALLERGY REACTION, AS THE REDNESS OCCURRED ON THE SKIN SURROUNDING ALL FOUR (4) CANNULAS. THERE WAS NO ALLEGATION OF ARCING/SPARKING/SMOKING DURING SURGERY. THE ESR WAS NOT AWARE OF ANY MEDICAL INTERVENTION THAT WAS DONE FOR THE PATIENT OR IF THE PATIENT HAD AN ALLERGY TO NICKEL. THE PATIENT WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154111 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

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