BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 24814991 · Received April 8, 2026

    Report

    Report Number
    2955842-2026-20791
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 8, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K181395
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED. IMAGE SHOWS A CANNULA SEAL WITH A TORN DUCKBILL. THERE APPEARS TO BE A BLACK COLORED DETACHED FRAGMENT SIMILAR IN SIZE AND SHAPE TO THE DUCKBILL TEAR AT THE BOTTOM OF THE IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER THOUGHT THE BROKEN PIECE WAS CHAR FROM CAUTERY. THE CUSTOMER WAS ABLE TO GRAB IT AND REMOVE IT FROM THE PATIENT. THEY REALIZED IT WAS RUBBERY INSTEAD OF CHAR. AT THE END OF THE CASE THE SURGICAL TECH NOTICED THE SEAL WAS BROKEN WHEN SHE REMOVED IT FROM THE METAL TROCAR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS VISUALLY INSPECTED FOR SEAL INTEGRITY PRIOR TO USE, BUT THE RUBBER PORTION WAS NOT CLOSELY EXAMINED. THE DEVICE FRAGMENT WAS DISCOVERED ABOUT ONE HOUR INTO THE PROCEDURE DURING INSTRUMENT CHANGES AT A PORT, THOUGH THE EXACT TIMING AND CAUSE OF THE BREAKAGE ARE UNKNOWN AND THE SURGEON DID NOT OFFER A COMMENT, EXCEPT TO REQUEST REPORTING. NO FUNCTIONAL ISSUES OR INSTRUMENT COLLISIONS WERE NOTED BY THE SURGICAL TEAM. FRAGMENTS WERE RETRIEVED BY THE SURGEON, WHO ORIGINALLY THOUGHT THE MATERIAL WAS CHAR, USING AN INSTRUMENT THROUGH THE ACCESSORY PORT, AND THE TEAM WAS FAIRLY CONFIDENT ALL PIECES WERE REMOVED BASED ON THE DEFECT OBSERVED IN THE SEAL, THOUGH THEY COULD NOT VERIFY THIS WITH ABSOLUTE CERTAINTY; NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE IMAGING WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT FURTHER COMPLICATION, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL POST-OPERATIVELY. THE SEAL WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875253 DA VINCI SEAL GCJ INTUITIVE SURGICAL, INC 470500 N/A

    Patients

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