BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15990671 · Received December 15, 2022

    Report

    Report Number
    2955842-2022-15919
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 15, 2022
    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
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECTION AND CONFIRMED THAT THE MONOPOLAR WAS NOT DETECTED ON THE ERBE PORT. THE FSE REPLACED THE ERBE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ERROR ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS OF THE RETURNED UNIT CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE ERBE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. VISUAL INSPECTION FOUND THE UNIT TO BE IN GOOD CONDITION. EVENT VERIFICATION VIA SYSTEM LOG REPORT REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM: (B)(4). NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE MONOPOLAR PORT HAD RECOGNITION FAILURE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AFTER THE START OF THE PROCEDURE. ALSO, COMPLAINT INVESTIGATION CONFIRMED THAT THE FIELD SERVICE ENGINEER (FSE) REPLACED THE IESU TO RESOLVE THE ISSUE. 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 THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENTS INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR PORT HAD RECOGNITION FAILURE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER MOVED THE MONOPOLAR ENERGY CABLE FROM PORT 1 AND PORT 2, REPLACED THE ENERGY CABLE AND THE INSTRUMENT; HOWEVER, THE SAME ISSUE PERSISTED. THE CUSTOMER WAS ABLE TO CONTINUE THE PROCEDURE USING THE SAME IESU GENERATOR. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. DURING THE PROCEDURE, THE CUSTOMER REPLACED THE MONOPOLAR CORD, THE INSTRUMENT AND PERFORMED POWER CYCLE OF THE IESU. THE CUSTOMER CONTINUED THE PROCEDURE WITH THE SAME IESU. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512312 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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