BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 20683160 · Received November 14, 2024

    Report

    Report Number
    2955842-2024-21916
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSE). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION. .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THIS PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ¿ERRORS 25803 AND 307¿ WERE CONFIRMED AND REPLICATED. BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THE SYSTEM IS FAULTING OUT. THE CUSTOMER INFORMED PATIENT SIDE MANIPULATOR (PSM3) HAD A FAULT WHEN INSTALLING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND NOW THEY ARE POWER CYCLING THE SYSTEM. THE SYSTEM LOGS CONFIRM PATIENT SIDE MANIPULATOR (PSM)3 ERRORS. THE SYSTEM POWERED BACK ON SUCCESSFULLY, BUT THE SYSTEM FAULTED WITH RECOVERABLE ERROR 23078 POINTING TO A STERILE ADAPTER SIGNAL RANGE ERROR AS SOON AS THE CUSTOMER INSTALLED THE MCS INSTRUMENT ON PSM3, FOLLOWED BY NON-RECOVERABLE ERROR 307 POINTING TO PSM3 OLED. THE CUSTOMER POWER CYCLED THE SYSTEM AGAIN AND THE SYSTEM POWERED ON SUCCESSFULLY. THE TSE RECOMMENDED RESEATING THE STERILE ADAPTER ON PSM3 AND CHECKING IF THE MCS INSTRUMENT ENGAGES SUCCESSFULLY ON ANOTHER PSM. THE CUSTOMER INSTALLED THE MCS INSTRUMENT ON PSM2 AND THE INSTRUMENT ENGAGED SUCCESSFULLY WITH NO ERRORS. THE CUSTOMER THEN ELECTED TO INSTALL A NEEDLE DRIVER INSTRUMENT ON PSM3, AND THE INSTRUMENT ENGAGED SUCCESSFULLY WITH NO ERRORS. THE TSE ASKED THE CUSTOMER TO TRY RE-INSTALLING THE MCS INSTRUMENT ON PSM3 AGAIN TO CHECK IF THE ERROR RETURNS AFTER RESEATING THE STERILE ADAPTER. THE CUSTOMER DID NOT WANT TO RISK CAUSING ANOTHER SYSTEM FAULT AND ELECTED TO CONTINUE WITH THE PROCEDURE. THE TSE RECOMMENDED INSTALLING THE MCS INSTRUMENT ON PSM3 AGAIN AFTER THE PROCEDURE TO CHECK IF THE INSTRUMENT ENGAGES SUCCESSFULLY WITH NO ERRORS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER CONFIRMED ARM3 WAS DISABLED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285133 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-44 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES