BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16029681 · Received December 21, 2022

    Report

    Report Number
    2955842-2022-16061
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE SYSTEM FUNCTIONALITY INCLUDING SELF-TEST WAS CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. THE LIGHT SOURCE WENT OUT REPORTEDLY OCCURRED HALF AN HOUR AFTER THE START OF THE OPERATION. THEREFORE, THE PROCEDURE WAS CONVERTED TO A COMMON LAPAROSCOPIC SURGERY. THE SURGICAL STAFF DID NOT ADD ANY OTHER INCISIONS DUE TO THE PROCEDURE CONVERSION. THE PROCEDURE WENT ON AND LASTED FOR 9.6 HOURS. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT INJURY AND NO POST-OPERATIVE COMPLICATIONS AS A RESULT OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE LIGHT SOURCE SUDDENLY WENT OUT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) LAMP MODULE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED POST-EVALUATION AND/OR IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE PROCEDURE LOG RESULTED IN NO ADDITIONAL INFORMATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) CONTRIBUTED TO THE PROCEDURE BEING CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY. ALTHOUGH NO PATIENT HARM WAS REPORTED, IF THE ALLEGED MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LAMP MODULE WAS ANALYZED AND FOUND TO HAVE NO ISSUE. THE LAMP MODULE WAS PLACED IN AN IN-HOUSE SYSTEM, AND THE LIGHT OUTPUT WAS ILLUMINATED WITH NO ISSUES. THE HOUR USAGE WAS FOUND TO BE 96 HOURS USED. NO THERMAL DAMAGE WAS OBSERVED. THERE WAS NO TROUBLE FOUND WITH THIS LAMP MODULE. THE ROOT CAUSE IS NOT DETERMINABLE/APPLICABLE. THE CUSTOMER REPORTED COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE LIGHT SOURCE SUDDENLY WENT OUT. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840887 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-15 N/A 00886874110874

    Patients

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