BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 11830125 · Received May 16, 2021

    Report

    Report Number
    2955842-2021-10514
    Event Type
    Injury
    Date Received
    May 16, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 22, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS CONDUCTED ON 23-APR-2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. AN ISI FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE SYSTEM STOPPED REPORTING CASES VIA ONSITE BECAUSE OF AN UNRELATED ICC BOARD REPLACEMENT ON SYSTEM SK1531 AND THAT THERE IS A GAP IN LOG RETRIEVAL THROUGH (B)(6) 2021. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS WAS NOT POSSIBLE FOR A RIGHT HEMICOLECTOMY PROCEDURE ON (B)(6) 2021 ON SYSTEM SK1531 DUE TO SAME. WHILE THE PATIENT EXPERIENCED UNKNOWN SYMPTOMS FOR WHICH A SECOND OPERATION WAS PERFORMED TO ADDRESS AN ALLEGED STAPLE LINE LEAK, THERE WAS NO REPORT OF INTRA-OPERATIVE COMPLICATIONS DURING THE INITIAL, SUCCESSFULLY COMPLETED, DA VINCI PROCEDURE AND THERE IS NO INFORMATION PROVIDED AT THIS TIME THAT MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. AT THIS TIME, ALTHOUGH SYSTEM AND INSTRUMENT LOGS ARE UNAVAILABLE FOR REVIEW, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT A DA VINCI PRODUCT, INSTRUMENT OR ACCESSORY MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. HOWEVER, THERE WAS ALLEGED POST-OPERATIVE LEAK THAT REQUIRED UNSPECIFIED REPAIR IN A SECOND PROCEDURE TO RESOLVE. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED ISSUE AND POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT DEVELOPED AN UNSPECIFIED ¿LEAK AT THE STAPLE LINE¿. THERE WAS NO REPORT OF INTRA-OPERATIVE SYSTEM OR INSTRUMENT ISSUES; NOT WITH SEALING OR STAPLING. THE SURGEON HAD USED FIREFLY INDOCYANINE GREEN (ICG) FLUORESCENT IMAGING DURING THE PROCEDURE AND CONFIRMED THAT TISSUE WAS PERFUSED. HOWEVER, THE PATIENT DEVELOPED ¿A STAPLE LINE LEAK¿ TWO WEEKS POST-OPERATIVELY. ON 27-APR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER A SUCCESSFULLY COMPLETED RIGHT HEMICOLECTOMY PROCEDURE FOR ¿CANCER TUMOR REMOVAL¿ ON (B)(6) 2021, THE PATIENT RETURNED TO THE HOSPITAL APPROXIMATELY FOUR OR FIVE DAYS POST-OPERATIVELY PRESENTING WITH SYMPTOMS OF NAUSEA AND VOMITING WHICH LED THE SURGEON TO SUSPECT ¿A LEAK¿. THE SAME SURGEON PERFORMED A REOPERATION ON APPROXIMATELY THE FIFTH DAY POST-OPERATIVELY. THE SURGEON FOUND AN ANASTOMOTIC LEAK AT THE ILEUM COMMON STAPLE LINE WHERE A SUREFORM 60 STAPLER AND BLUE RELOAD HAD BEEN USED. THE ANASTOMOTIC LEAK WAS REPAIRED SURGICALLY BY UNSPECIFIED MEANS DURING A REOPERATION ON AN UNSPECIFIED DATE. THE REOPERATION COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REPORTED AS DOING ¿FINE NOW¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726641 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1