BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 20578442 · Received October 31, 2024

    Report

    Report Number
    2955842-2024-21337
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER WAS ABLE TO RECOVER BY RESEATING THE TUBE SET, STOPPING INSUFFLATION, AND STARTING THE INSUFFLATOR BACK UP. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND UI ALERTS FOR WHEN THE INSUFFLATOR HOUSE GAS WAS LOW, THEN TUBE SET WAS DISCONNECTED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECTOPEXY SURGICAL PROCEDURE, THERE WAS A LOSS OF INSUFFLATION. THE PRESSURE COMPLETELY DROPPED TO ZERO IN A RAPID FASHION. HOWEVER, THE CUSTOMER WAS ABLE TO RECOVER BY RESEATING THE TUBE SET, STOPPING INSUFFLATION, AND STARTING THE INSUFFLATOR BACK UP. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND UI ALERTS FOR WHEN THE INSUFFLATOR HOUSE GAS WAS LOW, THEN TUBE SET WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED ISSUE; HOWEVER, NO FURTHER ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848731 DA VINCI SEAL NAY INTUITIVE SURGICAL, INC 470380 N/A

    Patients

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