BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17313266 · Received July 12, 2023

    Report

    Report Number
    2955842-2023-17002
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 19, 2023
    Report Date
    June 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE ANALYSIS TEAM HAS COMPLETED THEIR INVESTIGATION ON THE PATIENT SIDE MANIPULATOR (PSM). THE PSM WAS ANALYZED, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED, BUT COULD BE CONFIRMED AS HAVING OCCURRED VIA THE FIELD ERROR LOGS. VISUAL INSPECTION WAS PERFORMED. THE PSM WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. A SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. ADDITIONAL TESTS PERFORMED WERE PASSED. NO TROUBLE WAS FOUND ON THE PSM.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM 1 WAS ALARMING WITH ERROR 25596. AN INVESTIGATION IS IN PROGRESS 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. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO SOLVE MULTIPLE 25596 ERRORS OF ARM 1 AT STARTUP. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE AND THE PSM HAS BEEN RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ARM 1 WAS ALARMING WITH ERROR 25596. THE CUSTOMER POWER CYCLED THE SYSTEM MULTIPLE TIMES ALREADY, BUT THE ERROR RETURNED. THE TSE CONFIRMED THE PRESENCE OF ERROR 25596 IN THE LOGS, AND IT WAS LEADING TO AN ERROR 30 POINTING TO A FAULT ON PATH REMOTE ARM CONTROLLER BOARD (RAC) 1 TO PATIENT SIDE MANIPULATOR (PSM) 1. AS A LAST CHANCE, THE TSE GUIDED THE CUSTOMER TO HARD POWER CYCLE ARM 1, BUT THE ERROR RETURNED AT POWER UP. THE TSE ASKED THE CUSTOMER IF THE SURGEON WAS OKAY TO RESUME THE SURGERY WITH THREE ARMS AND THE CUSTOMER AGREED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281831 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-15 N/A 00886874110690

    Patients

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