BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19292846 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14288
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874114817
    PMA / PMN Number
    K162973
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SUCTION IRRIGATOR INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A PIECE MEASURING APPROXIMATELY 0.089" X 0.203" BROKEN OFF AT THE DISTAL END. COMPONENTS ADJACENT TO THIS BROKEN GRIP DO NOT SHOW DAMAGE. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) HAD BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGES WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER, AND THE LOCATION OF WHERE THE FRAGMENT CAME FROM COULD NOT BE DETERMINED BASED ON THE PHOTOS PROVIDED.

    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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER USED A SUCTION IRRIGATOR INSTRUMENT, AND A TIP OF PLASTIC BROKE OFF. THE INSTRUMENT WAS STILL FUNCTIONAL, AND THE BROKEN PIECE WAS RETRIEVED AND THROWN IN THE GARBAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530507 ENDOWRIST SUCTION IRRIGATOR NAY INTUITIVE SURGICAL, INC 480299-06 K16230727 0144 10886874114817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES