BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 20725556 · Received November 19, 2024

    Report

    Report Number
    2955842-2024-21462
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 15, 2024
    Report Date
    October 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY TO PERFORM FAILURE ANALYSIS. THE MCS TIP COVER ACCESSORY WAS ANALYZED AND FOUND TO HAVE TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT, CAUSING THE TIP COVER TO APPEAR LOOSE. THE TEAR IS AXIALLY ALIGNED WITH THE TIP COVER AND MEASURES APPROXIMATELY 0.144" IN LENGTH. THERE IS A SMALL FRAGMENT OF MATERIAL THAT APPEARS TO BE MISSING. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY DID NOT HAVE A CUT OR TEAR. NO ARCING WAS OBSERVED. THE CUSTOMER HAD USED THE MCS TIP COVER ACCESSORY INSTALLATION TOOL. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED ON THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT APPLY ANY LUBRICANT TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE MCS TIP COVER ACCESSORY. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938393 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 K10240306 10886874111045

    Patients

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