BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 18275891 · Received December 6, 2023

    Report

    Report Number
    2955842-2023-20995
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 14, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K181395
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SEAL ACCESSORY WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. THE UNIVERSAL SEAL WAS FOUND TO HAVE A BROKEN PIECE. THE BROKEN PIECE WAS FROM THE DUCKBILL; HOWEVER, THE BROKEN PIECE WAS RETURNED WITH THE RECEIVED SEAL. THE MISSING PIECE WAS APPROXIMATELY 0.161" X 0.324" IN SIZE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF BLACK RUBBER BROKE OFF OF THE SEAL AND FELL INTO THE SURGICAL SITE. THE PROCEDURE AND THE PATIENT OUTCOMES ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS ROBOTICALLY COMPLETED. PER THE SURGEON'S OPERATION NOTE AND DISCHARGE SUMMARY, THE FRAGMENT OF THE PORT WAS NOT EVEN MENTIONED. THE PATIENT WAS DISCHARGED ON TIME, AND IN STABLE CONDITION. NO PATIENT INJURY OR HARM WAS REPORTED. NO MEDIA IS AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772617 DA VINCI SEAL GCJ INTUITIVE SURGICAL, INC 470500-13 K10230630

    Patients

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