BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21923850 · Received April 29, 2025

    Report

    Report Number
    2955842-2025-17414
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE HAD THE ERBE GENERATOR REPLACED. AFTER REINSTALLING THE GENERATOR BACK INTO SYSTEM SK0230, THE SYSTEM PASSED ALL TESTS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO SYSTEM CHECKMASTER RELATED ELECTRICAL AND FIBEROPTIC ISSUES ON THE ERBE IESU. THE ISSUE WAS RESOLVED BY REPLACING THE DEFECTIVE UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, BIOMED PULLED ERBE FROM VSC ON SK0230 TO USE IN PLACE OF ANOTHER ERBE THAT FAILED DURING A CASE WITH SK5171. AFTER COMPLETING THE ERBE REPLACEMENT ON SK5171, RE-INSTALLED ERBE THAT WAS PULLED BY BIOMED [ P/N 951300-03 S/N (B)(6)]. THE ERBE WAS RE-INSTALLED BACK INTO SK0230 IN ACCORDANCE WITH ISI PROCEDURES. THE SYSTEM PASSED ALL REQUIRED TESTS. ELECTRICAL SAFETY AND SYSTEM VERIFICATION SUCCESSFULLY COMPLETED. SYSTEM READY FOR USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485081 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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