BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 19746226 · Received July 15, 2024

    Report

    Report Number
    2955842-2024-16940
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 20, 2024
    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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE UNIVERSAL SEAL FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE UNIVERSAL SEAL PART OF SEAL BROKE OFF AND WAS FOUND IN THE PATIENT. THE PIECE WAS LOCATED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. ON 20-JUN-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: PART OF SEAL BROKE OFF AND WAS FOUND IN PATIENT. THE PIECE WAS LOCATED AND REMOVED FROM PATIENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500898 NONE SEAL GCJ INTUITIVE SURGICAL, INC 470500-06 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES