BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20078542 · Received August 27, 2024

    Report

    Report Number
    2955842-2024-18273
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 30, 2024
    Report Date
    July 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE PERFORMED A TEST DRIVE. THE FSE PERFORMED BURN WITH BIPOLAR AND MONOPOLAR ENERGY FROM THE ERBE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PERMANENT CAUTERY HOOK INVOLVED WITH THE COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT SPARKED WHEN APPLYING ENERGY DURING USE. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE INSTRUMENT WAS REMOVED, AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE CUSTOMER STATED THEY WERE USING OXYGEN TO VENTILATE THE PATIENT'S LUNG, AND THEY BELIEVED THAT A LEAK HAD OCCURRED, WHICH RESULTED IN A SPARK IGNITING THE GAS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494625 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-16 K11230405 0106 00886874112311

    Patients

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