BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20242552 · Received September 17, 2024

    Report

    Report Number
    2955842-2024-19406
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K181395
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REACHED OUT TO THE ISI CLINICAL SALES REPRESENTATIVE (CSR) TO ADVISE OPERATING ROOM STAFF ON CANNULA SEAL LEAKING. NO SITE VISIT WAS CONDUCTED. ISI HAS NOT RECEIVED THE UNIVERSAL SEAL FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT SITE WAS LOSING INSUFFLATION WHEN THEY INSERT AN ENDOSCOPE OR INSTRUMENT. THE TSE SUGGESTED ANOTHER CANNULA OR SEAL. SITE TRIED DIFFERENT "CAPS" AND THEY WERE GOING TO TRY A NEW CANNULA. THE CUSTOMER REQUESTED SUPPORT REGARDING THE HASSON CONE. THE TSE EXPLAINED THAT THEY HAD NO SUGGESTIONS TO STOP THE AIR FROM LEAKING. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361016 NONE SEAL GCJ INTUITIVE SURGICAL, INC 470500-13 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES