BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24586220 · Received March 12, 2026

    Report

    Report Number
    2955842-2026-15715
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A REVIEW OF THE EVENT WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "THE PATIENT IN THIS REPORT DEVELOPED A POST-OPERATIVE LEAK FOLLOWING THEIR PANCREATICODUODENECTOMY. THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION. THIS COMPLICATION IS A COMMON COMPLICATION FOLLOWING A PANCREATICODUODENECTOMY (1,2) AND IS MOST LIKELY RELATED TO THE PROCEDURE ITSELF ALTHOUGH THE OCCURRENCE OF THIS COMPLICATION IS NOT SPECIFIC TO THE DA VINCI DEVICE. THERE IS NO EVIDENCE THIS COMPLICATION IS RELATED TO THE JURA SYSTEM OR JURA PROCEDURE." 1. ABU-ZEID EED, GARZALI IU, ALOUN A, SHESHE AA. ISOLATED ROUX-EN-Y VERSUS SINGLE LOOP PANCREATICOJEJUNAL RECONSTRUCTION AFTER PANCREATICODUODENECTOMY - A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS. S AFR J SURG. 2024 MAY;62(2):28-32. PMID: 38838116. 2. FATHY O, WAHAB MA, ELGHWALBY N, SULTAN A, EL-EBIDY G, HAK NG, ABU ZEID M, ABD-ALLAH T, EL-SHOBARY M, FOUAD A, KANDEEL T, ABO ELENIEN A, ABD EL-RAOUF A, HAMDY E, SULTAN AM, HAMDY E, EZZAT F. 216 CASES OF PANCREATICODUODENECTOMY: RISK FACTORS FOR POSTOPERATIVE COMPLICATIONS. HEPATOGASTROENTEROLOGY. 2008 MAY- JUN;55(84):1093-8. PMID: 18705336. ADDITIONAL PATIENT INFORMATION: HEIGHT 183 CM., BODY MASS INDEX (BMI) 36.4 KG/M2.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI AND JURA SYSTEM ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE. SEVEN DAYS AFTER THE INDEX PROCEDURE, A LEAK AT THE PANCREATICOJEJUNOSTOMY (PJ) ANASTOMOSIS WAS IDENTIFIED. THE LEAK WAS DRAINED FOR FOUR DAYS THEN THE DRAIN WAS REMOVED WHILE THE PATIENT WAS STILL RECEIVING ANTIBIOTICS. A REPEAT COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED SHOWING A FLUID COLLECTION AT THE SAME LOCATION. IT WAS NOT ACCESSIBLE FOR DRAINAGE; THEREFORE, ADDITIONAL ANTIBIOTICS WERE STARTED. THE EVENT WAS RESOLVED 34 DAYS AFTER THE INDEX PROCEDURE, WHICH RESULTED IN A PROLONGED HOSPITALIZATION (WITHOUT INTENSIVE CARE UNIT ADMISSION). THERE WERE NO INTRA-OPERATIVE DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), A CLAVIEN-DINDO GRADE IIIA, POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE JURA SYSTEM, NOT RELATED TO THE DA VINCI SYSTEM AND NOT RELATED TO A THIRD-PARTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35782 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-32 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.