BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 16641106 · Received March 30, 2023

    Report

    Report Number
    2955842-2023-11629
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE TROCAR INJURY IS UNKNOWN. IT WAS REPORTED THAT THE TROCAR WAS NOT PLACED PROPERLY, INTERVENTION INCLUDED PUSHING IT IN FARTHER. THE PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. REVIEW OF THE SYSTEM LOGS SHOWED THERE WERE NO SYSTEM LOG ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT HAS BEEN REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI ASSISTED PROCEDURE, THE PATIENT'S RIB WAS BROKEN BY THE CANNULA WHILE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS BEING MANIPULATED. THE PORTION OF RIB PIECE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MEDIASTINAL LYMPH NODE DISSECTION, THE TROCAR BROKE A PIECE OF THE PATIENT'S RIB WHILE MOVING AN INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE FOLLOWING INFORMATION WAS OBTAINED OR CLARIFIED THROUGH FOLLOW UP WITH THE SITE: A SMALL PORTION OF RIB WAS BROKEN AND THEN REMOVED FROM THE BODY AFTER THE TROCAR WAS PLACED IN THE 7TH INTERCOSTAL SPACE, 5 CM AWAY FROM THE SPINE ON THE RIGHT SIDE. TO CONTINUE, THE TROCAR WAS REPOSITIONED AND PUSHED IN FARTHER. THERE WAS NO DAMAGE TO SURROUNDING TISSUE, NO MEDICAL INTERVENTION WAS PERFORMED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173353 NONE CANNULA, STANDARD, REUSABLE NAY INTUITIVE SURGICAL, INC 470002 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.