BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20197613 · Received September 12, 2024

    Report

    Report Number
    2955842-2024-19364
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. IMAGE REVIEW: A REVIEW OF THE PROVIDED IMAGES WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT LOOKS LIKE THE PROXIMAL CLEVIS GOT DISLODGED, AND THE MAIN TUBE IS BROKEN (FRAGMENTS IN THE FIRST PICTURE). FROM THE LAST TWO PICTURES, IT LOOKS LIKE THE CONDUCTOR WIRE MIGHT BE SLIGHTLY LOOSE. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED PRIOR TO THE RETURN AND ANALYSIS OF THE INSTRUMENT. NO FURTHER ESCALATIONS REQUIRED FOR THE IMAGE REVIEW.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A BROKEN MAIN TUBE APPROXIMATELY 1.85" FROM THE DISTAL TIP. NO MATERIAL WAS FOUND MISSING. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO NOT SHOW DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOTICED TO HAVE THE PLASTIC PART AT THE INSTRUMENT TIP DAMAGED, PREVENTING THE INSTRUMENT TO COME OUT OF THE CANNULA. THE CUSTOMER REMOVED THE CANNULA AND THE INSTRUMENT FROM THE PATIENT AND CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOR ASSISTANCE. WHILE SEPARATING FROM THE CANNULA, THE INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT AND THE PORT INCISION WAS NOT INCREASED TO REMOVE THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592719 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11240104 0025 00886874119792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES