BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI XI

    MDR report key: 19973030 · Received August 13, 2024

    Report

    Report Number
    2955842-2024-18124
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CORE REDUNDANT POWER TRAY ASSEMBLY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE REPORTED ERRORS 86 AND 90 COULD NOT BE REPRODUCED, HOWEVER THEY WERE CONFIRMED AND VERIFIED VIA ERROR LOGS AND SYSTEM LOGS. THE UNIT WAS INSTALLED AND TESTED ON THE FINAL TEST IS4000 SYSTEM 1, PROGRAMMED AND SYSTEM STARTED AT NORMAL MODE WITH NO ERRORS AND FAILURE MESSAGE. THE UNIT WAS POWER CYCLED 10X AND ALL PASSED. THE ASSEMBLY REMAINED ON THE SYSTEM IDLING IN NORMAL MODE, WITH NO FAILURES AND NO ERRORS. ALL ADDITIONAL TESTS PASSED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO THORACOSCOPIC SURGERY. THE PATIENT TOLERATED THE CHANGE, AND NO PATIENT INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE DEVICE FOR EVALUATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR 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.

    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 SURGICAL PROCEDURE, ERROR 90 OCCURRED WHILE DOCKING AND A POWER CYCLE DID NOT RESOLVE THE ISSUE. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO DO A HARD POWER CYCLE. THE CUSTOMER DID IT AND THE ISSUE WAS RESOLVED. TSE CHECKED THE LOG, ERROR 90 AND ERROR 86 WERE LOGGED. THE CUSTOMER CALLED BACK AND STATED THAT ERROR 86 REPEATED AGAIN AND THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682449 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-07 N/A 00886874115343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.