BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15455574 · Received September 20, 2022

    Report

    Report Number
    2955842-2022-14095
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION INFORMATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT THE UNIT TESTED ON AN IN-HOUSE SYSTEM AND INTERMITTENTLY FAILED NORMAL MODE AS IT TRIGGERED ERROR 32056. SYSTEM AND PROCEDURE LOGS SHOWED ERRORS 32056, 32058, 1123, 1173, 48100, AND 32101 AC_4E. DURING INSPECTION, FA FOUND NO DISCREPANCIES ON THE INSERTION AXIS. THE UNIT ALSO TESTED ON A PSC FIXTURE TEST PLATFORM (PFTP) AND IT PASSED ALL REQUIRED TESTS. AS A PRECAUTION, INSERTION CHIPENCODER VIRTUAL ABSOLUTE PRINTED CIRCUIT ASSEMBLY (CVA PCA) AND INSERTION SEARCHLIGHT PRINTED CIRCUIT ASSEMBLY (SL PCA) WILL BE REPLACED. AXES CONTROLLER SPAR PRINTED CIRCUIT ASSEMBLY (ACS PCA) WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM.

    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 FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM4) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM4 UNIT WAS RETURNED FOR EVALUATION, HOWEVER THE FAILURE ANALYSIS TESTING HAS NOT BEEN COMPLETED AT THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE EVALUATION AND IF ANY ADDITIONAL INFORMATION IS RECEIVED. A LOG REVIEW WAS PERFORMED AND THE FOLLOWING WAS CONFIRMED: THE PEDIATRIC ADRENALECTOMY WAS PERFORMED ON (B)(6) 2022 ON SYSTEM (B)(4). A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT ENGINEER (TSE). THE LOG REVEALED SYSTEM ERRORS THAT MOST LIKELY RELATED TO THE REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER REPORTED AT THE END OF THE CASE, THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM4) WAS SHOWING REPEATED ERRORS, THE SURGICAL PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED WITH NO REPORTED INJURY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PEDIATRIC ADRENALECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT RIGHT AT THE END OF THE CASE, UNIVERSAL SURGICAL MANIPULATOR (USM4) KEPT FAULTING. PRIOR TO CALLING IN, THE CUSTOMER POWER CYCLED THE SYSTEM TWICE AND EACH TIME THE ERROR CAME BACK AS SOON AS THE SYSTEM TURNED ON. THE TSE REVIEWED THE LOGS AND USM4 WAS HAVING REPEATED 1123 ,1173 AND 48100 ERRORS. THE TSE HAD THE CUSTOMER HARD POWER CYCLE THE PATIENT SIDE CART (PSC), AND WHEN THE SYSTEM CAME BACK UP, IT FAULTED AGAIN. THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL PATIENT/EVENT 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
    2698859 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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