BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 15247103 · Received August 18, 2022

    Report

    Report Number
    2955842-2022-13508
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    June 30, 2022
    Report Date
    July 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) IS NOT EXPECTING ANY PRODUCT TO BE RETURNED AS PART OF THIS COMPLAINT, AS THERE WAS NO ALLEGATION OF A PRODUCT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF A DA VINCI PROCEDURE. THERE WAS NO KNOWN ISSUE WITH THE DA VINCI SYSTEM THAT CONTRIBUTED TO THE DECISION TO CONVERT THE PROCEDURE. THE PATIENT WAS SAID TO HAVE TOLERATED THE PROCEDURE WITH NO REPORTED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY BASED ON COMFORT LEVEL. THE SURGEON HAD PLANNED TO CONVERT TO OPEN AND THE ROOM WAS ALREADY SETUP. THERE WERE NO DA VINCI CONTRIBUTING FACTORS TO CONVERTING THE PROCEDURE; THIS WAS A DECISION MADE COMPLETELY BY THE SURGEON. THE CUSTOMER FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025508 DA VINCI DA VINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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