BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20253487 · Received September 19, 2024

    Report

    Report Number
    2955842-2024-19670
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE GRIP AXIS PIN DISLODGED FROM THE GRIPS. THE PIN WAS NOT RETURN WITH THE INSTRUMENT. GRIPS AND OTHER COMPONENTS ADJACENT TO THE DISLODGED PIN DID NOT SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSVERSUS ABDOMINIS RELEASE (TAR) VENTRAL HERNIA SURGICAL PROCEDURE, THE JAWS OF THE PROGRASP FORCEPS INSTRUMENT WERE LOOSE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY AND WITH NO DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND CONFIRMED THAT THE INSTRUMENT HAS BEEN DAMAGED DURING THE PROCEDURE. IT WAS STATED THAT NORMAL USE OF THE INSTRUMENT WAS PERFORMED. INSTRUMENT STOPPED WORKING AND THEY STATED THAT THE "SPLINT BETWEEN INDUSTRIES LOOSENED." INSTRUMENT WAS REMOVED WITH THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533032 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K10240125 0217 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES