BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14842867 · Received June 28, 2022

    Report

    Report Number
    2955842-2022-12504
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 15, 2021
    Report Date
    June 15, 2021
    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
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONFIRMED/REPRODUCED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM UNDER NORMAL MODE AND FAILED. THE UNIT WAS RETURNED TO OEM FOR REPAIR. DURING INSPECTION, IT WAS OBSERVED THAT THE HF GENERATOR PCB, THE BOTTOM EPAC AND THE HEAT SINK HAD THERMAL DAMAGE. ALL WERE REPLACED, WHICH CORRECTED THE BIPOLAR PROBLEM. A REVIEW OF THE SITE'S COMPLAINT HISTORY DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE BIPOLAR ENERGY INSTRUMENT DID NOT OPERATE AS EXPECTED WHEN CONNECTED TO PRIMARY ERBE GENERATOR. DURING TROUBLESHOOTING, THE CLINICIAN EXPERIENCED AN ELECTRICAL SHOCK. A BACKUP GENERATOR WAS USED TO RESOLVE THE ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, BIPOLAR ENERGY WAS NOT WORKING. THE SITE WAS ABLE TO USE MONOPOLAR ENERGY. THE BIPOLAR INSTRUMENT AND ENERGY CORD WERE REPLACED WITH NO CHANGE. THE CUSTOMER CONFIRMED THAT THE ICON INDICATOR LIGHT WAS ON AND THERE WERE AUDIBLE TONES. THE ERBE WAS WORKING INITIALLY BUT KEEP GIVING ERROR MESSAGES WHEN USING BIPOLAR ENERGY. THE ERBE WAS POWER CYCLED AND INITIALLY WORKED FOR A SECOND BEFORE THE ERRORS RETURNED. THE USER SWITCHED TO A BACKUP GENERATOR TO COMPLETE THE CASE. ON 23-JUN-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE¿S ROBOTIC COORDINATOR (RC) WHO REPORTED THAT WHEN THEY ATTEMPTED TO UNPLUG THE BIPOLAR CORD AND RESET THE ERBE DURING TROUBLESHOOTING, SHE WAS "SHOCKED" BY THE GENERATOR. THE RC DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AND NO PERMANENT IMPAIRMENT OR INJURY WAS REPORTED. THERE WAS NO DAMAGE SEEN IN THE CORD OR INSTRUMENTS. THERE WAS NO FRAGMENT FELL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO ADVERSE PATIENT IMPACT WAS REPORTED. THERE WAS NO ARCING OR SPARKING REPORTED. THE PATIENT DEMOGRAPHIC INFORMATION/MEDICAL HISTORY/RELEVANT INVESTIGATIONS WERE REQUESTED BUT WAS NOT PROVIDED. THE MARYLAND BIPOLAR FORCEPS WILL NOT BE RETURNED FOR INVESTIGATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044314 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 951300-03 N/A 00886874115343

    Patients

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