BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 14902892 · Received July 4, 2022

    Report

    Report Number
    2955842-2022-12780
    Event Type
    Malfunction
    Date Received
    July 4, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 COMPLAINT. THE MONOPOLAR ENERGY WAS NOT ACTIVATED WITH ERROR 32208 AND THE 4 LEDS OF THE ENERGY SHIELD MONITOR (ESM) WAS BLINKING AMBER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. AFTER COMPLETING THE LAPAROSCOPIC PROCEDURE, THE FSE WAS ABLE TO REPRODUCE THE ISSUE WHEN CONNECTING THE MONOPOLAR CABLE TO THE ESM. THE FSE REPLACED THE ESM, AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE ESM UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS REPLICATED. THE UNIT WAS INSTALLED INTO THE TEST SYSTEM AND IT FAILED. ALL LEDS WERE BLINK AMBER. THE CSM BOARD WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY AN ISI CLINICAL DEVELOPMENT ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE LED LIGHTS ON THE ESM ARE ALL FLASHING IN THE ONE SECOND VIDEO, BUT THERE IS NOTHING THAT I CAN MAKE OF IT. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO ERROR MESSAGE ON THE EXTERNAL MONITOR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ENERGY SHIELD MONITOR (ESM) DISPLAYED ERROR 32208. THE CUSTOMER PERFORMED POWER CYCLE OF THE SYSTEM WITH THE ESM WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE EVENT LOGS VIA ONSITE AND FOUND RECOVERABLE FAULT 32208 POINTED TO CAUTERY SHIELD MONITOR (CSM), WHICH WAS THE ESM¿S NODE. THE TSE ADVISED THE CUSTOMER TO REPLACE THE ENERGY CABLE AND THE INSTRUMENT. HOWEVER, THE SAME ISSUE PERSISTED AFTER REPLACEMENT OF THE ENERGY CABLE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER FOUND NO ISSUES DURING SET UP OF THE SYSTEM. THE ISSUE OCCURRED AT THE BEGINNING OF THE PROCEDURE WHEN THE CUSTOMER ATTEMPTED TO USE THE MONOPOLAR ENERGY. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. THE CUSTOMER BELIEVED THAT THE SYSTEM WAS MALFUNCTION. VIDEO RECORDING OF THE PROCEDURE WAS AVAILABLE FOR REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609461 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-45 N/A 00886874114742

    Patients

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