BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20388749 · Received October 7, 2024

    Report

    Report Number
    2955842-2024-20186
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    April 26, 2024
    Report Date
    September 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEYS. THE CABLE WAS FULLY BROKEN. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION ON THE CABLE THAT WOULD OCCUR FROM IMPROPER FLUSHING OR RINSING DURING REPROCESSING. FURTHER INSPECTION FOUND NOT ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT MAY CONTRIBUTE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT TENSION CORD TIP BROKE. THE SURGEON WAS NOTIFIED AND INSTRUCTED THE SCRUB TECHNICIAN TO REMOVE THE INSTRUMENT AND ALL PIECES WERE OBTAINED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 09/10/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: DURING SURGERY THE TENSION CORD OF THE MEGA SUTURECUT NEEDLE DRIVER TIP BROKE. SURGEON WAS NOTIFIED AND HE INSTRUCTED SCRUB TECH TO REMOVE THE NEEDLE DRIVER. ALL PIECES WERE OBTAINED. CHARGE NURSES WERE NOTIFIED AND INSTRUCTED ME TO SAVE ALL PIECES AND PLACE THEM IN A BIOHAZARD BAG. MEGA SUTURECUT NEEDLE DRIVER 8MMDA VINCI XI SURGICAL SYSTEMVER-16LOT# K10231207 0345 REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214237 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10231207 0345 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES