BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14869303 · Received June 30, 2022

    Report

    Report Number
    2955842-2022-12626
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    September 15, 2021
    Report Date
    September 21, 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
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DAVINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SYSTEM LOG REVIEW WAS CONDUCTED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS ADMITTED TO THE ER A FEW DAYS POST-OPERATIVELY WITH COMPLAINTS OF RIGHT ABDOMEN PAIN. HOWEVER, THE CAUSE AND SOURCE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. IT IS ALSO UNCLEAR WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE POST-OPERATIVE RIGHT ABDOMINAL PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, PATIENT WENT TO THE EMERGENCY ROOM (ER) AS A ¿WALK-IN¿ A FEW DAYS POST-OPERATIVELY WITH COMPLAINTS OF RIGHT ABDOMEN PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL SAME DAY FOR OBSERVATION AND DIAGNOSTICS. IT WAS INITIALLY SUSPECTED BY AN ER DOCTOR THAT THE PATIENT HAD A BILE LEAK, GIVEN THAT A CHOLECYSTECTOMY PROCEDURE HAD RECENTLY BEEN PERFORMED A FEW DAYS EARLIER. HOWEVER, AFTER CONDUCTING AN HEPATOBILIARY IMINODIACETIC ACID (HIDA) SCAN AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SCAN, IT WAS CONFIRMED THAT THERE WAS NO BILE LEAK. THE SURGEON WAS UNSURE WHERE THE PAIN WAS COMING FROM BUT INDICATED THAT IT DID NOT SEEM AS THOUGH THE PAIN WAS ASSOCIATED WITH THE CHOLECYSTECTOMY PROCEDURE. WHILE THERE WAS AN INITIAL REPORT FROM HOSPITAL STAFF OF BILE COLLECTION THAT WAS PUSHING ON THE PATIENT¿S DUODENUM AND THAT A DRAIN WAS PLACED, IT WAS CONFIRMED THAT THE UNSPECIFIED ISSUE RESOLVED ON ITS OWN AND THAT THEY WERE STILL DIAGNOSING THE ISSUE. THE SURGEON TOLD THE INTUITIVE SURGICAL INC, (ISI) REPRESENTATIVE THAT THIS WAS NOT FROM THE PROCEDURE, THE PROCEDURE WENT REALLY WELL, AND IT WAS AN EASY GALLBLADDER. THE PATIENT HAS BEEN DISCHARGED, UNSPECIFIED DATE, AND IS DOING WELL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890714 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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