BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15526115 · Received October 2, 2022

    Report

    Report Number
    2955842-2022-14340
    Event Type
    Malfunction
    Date Received
    October 2, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER SWAPPED OUT THE UNIVERSAL SEAL WITH A BACKUP TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. AN RFE PROCEDURE REVIEW CONFIRMED THAT THE INCISIONAL HERNIA IPOM PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA SYSTEM (B)(4). THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE UNIVERSAL SEAL TO THE PORT BROKE WHILE INSIDE THE PATIENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE UNIVERSAL SEAL BROKE AND HAD TO BE REPLACED IN PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610453 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

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