BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17579889 · Received August 18, 2023

    Report

    Report Number
    2955842-2023-17851
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 27, 2023
    Report Date
    July 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE SITE USED THE MONOPOLAR ENERGY TO RESOLVE THE PROBLEM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE USED THE MONOPOLAR ENERGY AND PROCEEDED WITH THE PROCEDURE AS PLANNED. THE ISSUE WAS RESOLVED BY USING ANOTHER ACTIVATION CABLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME ELECTRO SURGICAL UNIT (ESU).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIPOLAR DIDN'T WORK. INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE SYSTEM LOGS, NO RELATED ERRORS VERIFIED IN THE LOGS. SITE STATED NO ACTIVATION TONE WAS PRESENT ON ELECTROSURGICAL UNIT (ESU). ISSUE PERSISTED EVEN AFTER RESEATING THE ENERGY ACTIVATION CABLE ON PMED AND ESU AND TO TRY TO FIRE WITH BIPOLAR. THE ACTIVATION MESSAGE WAS PRESENT WHEN THE BIPOLAR PEDAL IS PRESSED. THE SURGEON DECIDED TO COMPLETE THE SURGERY USING ONLY THE MONOPOLAR ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329938 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-15 N/A 00886874110874

    Patients

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