BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14538888 · Received May 29, 2022

    Report

    Report Number
    2955842-2022-11888
    Event Type
    Malfunction
    Date Received
    May 29, 2022
    Date of Event
    April 24, 2022
    Report Date
    April 29, 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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THERE WERE TWO PROCEDURES PERFORMED ON (B)(6) 2022 AND BOTH PROCEDURE EXHIBITED THE SAME USM ARM ISSUE. THE REPORT SUBMITTED UNDER PATIENT IDENTIFIER (B)(6) DOCUMENTS THE FIRST DA-VINCI ASSISTED SURGICAL PROCEDURE WHILE THE REPORT SUBMITTED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT) DOCUMENTS THE SECOND PROCEDURE. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF MULTIPLE RECOVERABLE ERROR CODE 25730 ON (B)(6) 2022 USING SYSTEM SK5250 MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE'S INVESTIGATION. INFORMATION FROM PATIENT IDENTIFIER (B)(6) STATED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE DISTAL SUJ ON USM3. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE SUJ FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: A USM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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 CONVERSION/ABORTION. BLANK MDR FIELDS: THE EXPIRATION DATE IN SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, H3. ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SET UP JOINT (SUJ) AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT CONFIRM THE REPORTED COMPLAINT. WHEN THE UNIT WAS INSTALLED ON THE SYSTEM, NO ERRORS WERE TRIGGERED. THE UNIT FAILED AT NODE CHECK, MISSING MODE PERTAINING TO AXES CONTROLLER TORNADO (ACT) PCA. A GOLDEN ACT PCA WAS INSTALLED AND IT PASSED ALL TESTS. THE ORIGINAL ACT PCA WAS INSTALLED AND IT FAILED AGAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE SYSTEM GENERATED REPEATED ERRORS WHILE DOCKING THE PATIENT SIDE CART (PSC). THE CUSTOMER POWER CYCLED THE SYSTEM. HOWEVER; THE ISSUE REMAINED PERSISTENT. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE OCCURRENCE OF MULTIPLE RECOVERABLE ERROR CODE 25730 ON UNIVERSAL SURGICAL MANIPULATOR 3. UPON VERIFICATION, THE CUSTOMER SPECIFIED THAT THE SYSTEM WAS FUNCTIONALITY CHECKED UPON POWERING ON THE SYSTEM, AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE ISSUE OCCURRED APPROXIMATIVELY 10 MINUTES AFTER KNIFE TO SKIN DURING DOCKING WITH INSTRUMENTS. DURING THE CALL, USM3 WAS DISABLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT THE USE OF USM3. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND PATIENT DEMOGRAPHIC WAS PROVIDED AND CONFIRMED.

    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
    1582943 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES