BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19235987 · Received May 3, 2024

    Report

    Report Number
    2955842-2024-14175
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874114374
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SP MONOPOLAR CURVED SCISSORS (MCS) TIP ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE IMAGE PROVIDED APPEARS TO SHOW AN SP MCS INSTRUMENT WITH THE SP MCS TIP ACCESSORY¿S RETAINING COVER DISLODGED FROM THE INSTRUMENT. THERE DOES NOT APPEAR TO BE ANY MISSING PIECES FROM WHAT WAS SHOWN, BUT THE ACCESSORY WOULD NEED TO BE RETURNED FOR A FULL INSPECTION TO BE SURE, AS ONLY ONE OF THE RETAINING COVER¿S LANCES IS VISIBLE IN THE IMAGE. THE IMAGE APPEARS TO SHOW A POTENTIALLY DAMAGED RETAINING COVER. THE WHITE LINES ON THE EXTERIOR OF THE RETAINING COVER WHERE THE RETAINING LANCE SITS, IS TYPICALLY CAUSED BY THE INTERNAL RETAINING FEATURE BEING FORCED OUTWARDS. THIS DAMAGE CAN INDICATE MIS-INSTALLATION OF THE ACCESSORY WHICH CAN INCLUDE OVER-TWISTING THE RETAINING COVER ONTO THE INSTRUMENT TUBE ADAPTER, TWISTING THE RETAINING COVER BEFORE THE ACCESSORY IS PROPERLY SEATED ON THE INSTRUMENT, OR ATTEMPTING TO TWIST ON THE RETAINING COVER WITH THE ACCESSORY MISALIGNED WITH RESPECT TO THE INSTRUMENT TUBE ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT NIPPLE-SPARING MASTECTOMY WITH IMPLANT RECONSTRUCTION SURGICAL PROCEDURE, THERE WERE TWO INSTANCES OF THE SP MONOPOLAR CURVED SCISSORS (MCS) TIP DISENGAGING AFTER A COLLISION WITH THE FENESTRATION OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE SURGEON RECOGNIZED THE TIP DISENGAGED AND THE INSTRUMENT WAS REMOVED. A NEW TIP WAS THEN INSTALLED. THE TIP DID NOT FALL INTO THE PATIENT. THE CASE PROCEEDED AS NORMAL WITH JUST APPROXIMATELY 2 MINUTES OF SHORT DELAY TO INSTALL A NEW TIP ON THE INSTRUMENT FOR EACH INSTANCE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 01-MAY-2024: THERE WAS NO ARCING NOTED. CUSTOMER WILL NOT BE RETURNING THE SP MCS TIP. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420277 NONE MONOPOLAR CURVED SCISSORS (MCS) TIP NAY INTUITIVE SURGICAL, INC 430035-11 N/A 10886874114374

    Patients

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