BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20318714 · Received September 27, 2024

    Report

    Report Number
    2955842-2024-19956
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, ADDITIONAL INFORMATION WAS OBTAINED FROM THE INTUITIVE SURGICAL, INC. (ISI) ACCOUNT MANAGER. THE ACCOUNT MANAGER WAS NOT PRESENT FOR THE CASE. THE CUSTOMER ASKED THAT THE COMPLAINT BE REPORTED SO THE FIELD SERVICES ENGINEER (FSE) COULD CHECK THE STATUS OF THE UNIVERSAL SURGICAL MANIPULATOR (USM) IN QUESTION. FOLLOWING THAT, THE SYSTEM HAS BEEN FUNCTIONING NORMALLY.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD NOT REPRODUCE THE REPORTED ISSUE. THE FSE PERFORMED A MECHANICAL ADJUSTMENT/CALIBRATION TO CORRECT THE REPORTED PROBLEM. THERE WAS NO PART REPLACEMENT REQUIRED. THE SYSTEM WAS VERIFIED AND READY FOR USE. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 MOVED UNEXPECTEDLY. THE SURGEON STATED THE INSTRUMENT MOVED FROM INSIDE THE CANNULA TO INSIDE THE ABDOMEN UNASSISTED. THE INSTRUMENT CAME IN CONTACT WITH THE SMALL BOWEL, BUT THE SURGEON REPORTED THE PATIENT WAS NOT INJURED. THE LOGS WERE NOT AVAILABLE THE TIME OF THE CUSTOMER'S CALL WITH THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709914 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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