BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23854604 · Received December 19, 2025

    Report

    Report Number
    2955842-2025-49056
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112585
    PMA / PMN Number
    K162411
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN IMAGES PROVIDED BY THE CUSTOMER, IT COULD NOT BE CONFIRMED IF THE IMAGES SHOW THE DISTAL END OF THE 12-8MM REDUCER TROCAR. REVIEW OF ADDITIONAL IMAGES, CONFIRMED THE FOREIGN OBJECT IS THE DISTAL END OF THE 12-8MM REDUCER TROCAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A METALLIC FOREIGN BODY WITHIN THE ABDOMINAL CAVITY. PRIOR TO THE START OF THE PROCEDURE, THE 12-8MM REDUCER TROCAR WAS INSPECTED AND NO ABNORMALITIES OR DEFECTS WERE DETECTED. DURING THE PROCEDURE THE REDUCER TROCAR WAS NOT SUBJECTED TO ANY COLLISION OR ACCIDENTAL DROPPING. THERE WERE NO COMPLICATIONS NOTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. ON POSTOPERATIVE DAY (POD) #4, THE PATIENT DEVELOPED CHILLS AND WAS SUBSEQUENTLY DIAGNOSED WITH BACTEREMIA, CONFIRMED BY POSITIVE BLOOD CULTURES. UPON THE ONSET OF SEPSIS, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING AN INTACT ANASTOMOSIS BUT ALSO IDENTIFYING A METAL FOREIGN BODY AT THE PELVIC INLET. AFTER STABILIZATION WITH BROAD-SPECTRUM ANTIBIOTICS, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON POD #5, WHERE A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED TO RETRIEVE THE FOREIGN BODY; IDENTIFIED AS THE TIP OF THE PREVIOUSLY UTILIZED REDUCER TROCAR. IT WAS NOTED THAT POST-RETRIEVAL IMAGING (E.G., X-RAY OR ULTRASOUND) WAS NOT PERFORMED TO ASSESS FOR ADDITIONAL FRAGMENTS. FOLLOWING A PROLONGED HOSPITALIZATION AND A SEVEN-DAY COURSE OF ANTIBIOTICS TO ADDRESS BACTEREMIA, THE PATIENT WAS DISCHARGED AND SCHEDULED FOR ONGOING FOLLOW-UP IN THE CLINIC. DESPITE SUCCESSFUL MANAGEMENT, THE PHYSICIAN INDICATED THAT THE INCIDENT RAISES CONCERNS ABOUT POTENTIAL UNSPECIFIED LONG-TERM COMPLICATIONS FOR THE PATIENT. THE SURGERY WAS RECORDED AND REVIEWED BY TWO INDEPENDENT HIGHLY EXPERIENCED ROBOTIC SURGEONS AND THERE WAS NOTHING UNUSUAL DURING THE PROCEDURE. THERE WAS NO FOREIGN BODY THAT WAS NOTED ON THE FINAL EXPLORATION BEFORE THE PROCEDURE WAS CONCLUDED; THEREFORE, IT IS CONFIRMED THAT THE TIP OF THE REDUCER FELL OFF WHEN THE TROCAR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073420 ENDOWRIST REDUCER NAY INTUITIVE SURGICAL, INC 470381-12 K18240808 10886874112585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES