BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24518866 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15083
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    February 7, 2026
    Report Date
    March 5, 2026
    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
    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. ADDITIONAL PATIENT INFORMATION: HEIGHT 192 CM., BODY MASS INDEX (BMI) 26.9KG/M2. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) SURGICAL MEDICAL SAFETY OFFICER (MSO). "THE PATIENT IN THIS REPORT UNDERWENT A PANCREATICODUODENECTOMY FOR PANCREATIC CANCER AND HAD A COMPLICATION OF A FLUID COLLECTION REQUIRING IR DRAINAGE. THIS COMPLICATION IS NOT RELATED TO THE JURA DEVICE NOR THE JURA PROCEDURE. MULTIPLE COMPLICATIONS ARE WELL KNOWN TO OCCUR AFTER A PANCREATICODUODENECTOMY INCLUDING SURGICAL SITE INFECTION (23%), FISTULA FORMATION (21%), ACCUMULATION OF FLUID COLLECTIONS (12%), AMONG OTHERS. (REF 1). WHILE THE EXACT CAUSE OF THIS FLUID COLLECTION IS NOT PROVIDED, THERE IS A CAUSAL RELATIONSHIP BETWEEN THIS COMPLICATION AND A PANCREATICODUODENECTOMY PROCEDURE. THERE IS NO EVIDENCE THIS COMPLICATION WAS RELATED TO THE DA VINCI DEVICE." REF 1. F. KARIM SAM, ABDULLA KS, ABDULKARIM QH, RAHIM FH. THE OUTCOMES AND COMPLICATIONS OF PANCREATICODUODENECTOMY (WHIPPLE PROCEDURE): CROSS SECTIONAL STUDY. INT J SURG. 2018 APR;52:383-387. DOI: 10.1016/J.IJSU.2018.01.041. EPUB 2018 FEB 10. PMID: 29438817.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI AND JURA SYSTEM-ASSISTED PANCREATICODUODENECTOMY SURGICAL PROCEDURE. FOUR DAYS AFTER DISCHARGE, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH A PANCREATIC FISTULA AND AN ABSCESS AT THE PANCREAS ANASTOMOSIS (PANCREATICOJEJUNOSTOMY) WHICH WAS FOLLOWED BY READMISSION AND INITIATION OF ANTIBIOTICS (CEFTRIAXONE AND METRONIDAZOLE). TWO DAYS LATER, CIPROFLOXACIN WAS STARTED AND A RADIOLOGICAL DRAINAGE AND FLUID COLLECTION WAS PERFORMED. LABS AND CULTURE OF THE FLUID HAVE SHOWN HIGH AMYLASE AND BACTERIA SUPPORTING THE SUSPECTED FISTULA AND ABSCESS, RESPECTIVELY. THE EVENT HAS BEEN REPORTED AS RESOLVED THIRTEEN DAYS AFTER ADMISSION. THE INDEX PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS; NO MALFUNCTIONS WERE REPORTED WITH THE DA VINCI SYSTEM, ITS INSTRUMENTS OR ACCESSORIES, OR THE JURA SYSTEM. DISCHARGE OCCURRED SIX DAYS AFTER THE SURGICAL PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, A SERIOUS ADVERSE EVENT (REQUIRING HOSPITALIZATION), A CLAVIEN-DINDO GRADE IIIA, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE JURA SYSTEM, NOT RELATED TO THE DA VINCI SYSTEM, BUT POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583306 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.