BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21865119 · Received April 18, 2025

    Report

    Report Number
    2955842-2025-15938
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    November 22, 2024
    Report Date
    March 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PROGRASP FORCEPS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION, HOWEVER THE EVALUATION WAS NOT COMPLETE AT THE TIME OF THIS REPORT. THE EVENT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE LEFT INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT CABLE BROKE OFF INSIDE THE PATIENT. THE CABLE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICAL SALES REPRESENTATIVE (CSR) WAS NOT PRESENT DURING THE CASE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19374 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12240104 0088 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.