BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16892304 · Received May 8, 2023

    Report

    Report Number
    2955842-2023-12970
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR ON ERBE, 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. THE FSE REPLACED THE ERBE (PART NO: 951300-03, SERIAL NO: (B)(6)) PER ISI PROCEDURE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED, AND THE REPORTED ISSUE WAS REPLICATED. ERROR C-34 WAS DISPLAYED DURING BOOT UP. THE UNIT WOULD BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE ELECTROSURGICAL GENERATOR UNIT (ESU) WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP ESU. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE, ERROR C-34 OCCURRED ON THE ERBE GENERATOR. INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) SUGGESTED TO REBOOT BUT ISSUE DID NOT RESOLVE AFTER REBOOTING MULTIPLE TIMES. TSE ALSO HAD THE NURSE DISCONNECT FOOT PEDALS AND RESEAT THE POWER CABLE WITH NO CHANGE. THE TSE HAD THE NURSE VERIFY THAT THERE WAS NO COMPUTERIZED TOMOGRAPHY (CT) OR MAGNETIC SOURCES IN THE AREA AND THAT THE ERBE WAS ON ITS OWN DEDICATED CIRCUIT. THE TSE RECOMMENDED USING A FORCE TRIAD OR A SECONDARY TOWER. THE NURSE ACKNOWLEDGED AND MOVED TO END CALL TO FIND AN ALTERNATE ENERGY UNIT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227453 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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