BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 14862223 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12592
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    May 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    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. FSE REPLACED THE SSC MEDICAL GRADE POWER SUPPLY (MGPS) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS ABLE TO REPLICATE/CONFIRM THE REPORTED FAILURE. THERE WAS NO POWER IN THE SURGEON CONSOLE. THE FA REPORT INDICATED THAT THE FAN 2 DID NOT RUN AND THE LED INDICATOR WAS OUT. 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 PROCEDURE VIDEO WAS PROVIDED TO ISI FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) POWER WENT OUT. SUBSEQUENTLY, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IS NOT AVAILABLE. FIELDS ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) POWER WENT OUT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) STATED THE SURGEON CONSOLE WENT COMPLETELY BLACK WITH NO POWER TO IT. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) STATED THE LOGS REFLECT SEVERAL POWER ERRORS AND LOSS OF COMMUNICATION ERRORS. TSE ASKED THE CSR IF THERE WAS ANY LOSS OF POWER TO THE FACILITY. CSR REPORTED THE SYSTEM WAS NOT CONNECTED TO THREE DEDICATED 15 AMP POWER RECEPTACLES. FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND REPORTED THE SYSTEM WAS ALSO PLUGGED INTO A POWER STRIP. FSE AND CSR ENSURED THE SYSTEM WAS PLUGGED INTO THE THREE DIFFERENT RECEPTACLES AND THE POWERED UP THE SYSTEM WITH NO ISSUES. THE SURGEON ELECTED TO PERFORM THE PROCEDURE OPEN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957604 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-21 N/A 00886874110683

    Patients

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