BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 19736413 · Received July 12, 2024

    Report

    Report Number
    2955842-2024-16645
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PYELOPLASTY SURGICAL PROCEDURE, SP ACCESS PORT BEING USED RIPPED, AND INSUFFLATION WAS LOST. THIS OCCURRED WHILE THE SURGEON WAS ADJUSTING, AND THE BEDSIDE WAS ATTEMPTING TO INSERT A LAP INSTRUMENT IN THE BLUE PORT ON THE SIDE. THE SURGEON WAS NOTABLY TO THE RIGHT OF THE INCISION WHILE TRYING TO LOOK FURTHER RIGHT AND THE LAP TOOL WAS TO THE RIGHT OF THE INSTRUMENT CLUSTER. THIS COMBINATION LIKELY LED TO HIGH TORQUE BEING APPLIED TO THE PLASTIC OF THE ACCESS PORT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SEALS ON THE PORT WERE NOT SPECIFICALLY INSPECTED PRIOR TO USE BUT THERE WAS NOTHING OUT OF THE ORDINARY. ADJUSTING THE INSTRUMENT CLUSTER FROM LEFT TO RIGHT WITH A LAP ASSIST TOOL TO THE RIGHT OF THE CLUSTER TRYING TO INSERT FURTHER. LOSS OF INSUFFLATION WAS FAIRLY RAPID AS A 2-INCH HOLE IN THE AP CHAMBER WAS CREATED AND NO WAY TO HOLD INSUFFLATION ANYMORE. THERE WAS NO LOSS OF VISION AND THE SURGEON KEPT GOING FOR A COUPLE MINUTES BEFORE STOPPING AND WAITING FOR THE NEW ACCESS PORT TO BE PUT ON. THERE WERE NOT ANY INTRA-OPERATIVE COMPLICATIONS, AND THE SURGEON DID NOT EXPRESS ANY WHEN ASKED ABOUT THE LOSS OF INSUFFLATION AFTER THE CASE. ACCESS PORT WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903537 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-45 N/A 00886874114605

    Patients

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