BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15612302 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14601
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 14, 2022
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE SUREFORM STAPLER 60 INSTRUMENT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. A LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE DUODENAL SWITCH SURGICAL PROCEDURE WAS COMPLETED ON (B)(6)2022 VIA SYSTEM SK2566. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE INVESTIGATION REVEALED THE FOLLOWING SYSTEM ERROR 22020 RELATED TO STAPLER ENGAGEMENT ISSUES ON ARM 3 OF THE PATIENT CART. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAPAROSCOPIC SURGERY AFTER THE START OF THE PROCEDURE DUE TO THE ENGAGEMENT FAILURES WITH THE STAPLERS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DUODENAL SWITCH SURGICAL PROCEDURE, THE CUSTOMER CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY HAD ENGAGEMENT FAILURES WITH THE SUREFORM 60 STAPLER. CUSTOMER REPLACED THE STAPLER AND CONTINUED WITH THE PROCEDURE. TSE REQUESTED THE CUSTOMER RETURN THE FAILED STAPLER. THE CUSTOMER CALLED BACK AND REPORTED THAT THE SECOND STAPLER (LOT # 1022809) WOULDN'T ENGAGE. CUSTOMER THEN GOT ANOTHER STAPLER (LOT # 1022810) AND WAS ABLE TO FIRE ONCE AND THEN RELOADED IT AND THE REPLACEMENT STAPLER WOULD STOP WORKING ON ARM 3 OF THE PATIENT CART. THE SURGEON THEN ELECTED TO CONVERT TO LAPAROSCOPY BECAUSE OF THE STAPLER ISSUE. THE SURGEON STATED HE WILL NOT USE THE ROBOT FOR THE NEXT TWO CASE BECAUSE OF THE STAPLER ENGAGEMENT ISSUES. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY AND WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY DUE TO RECURRING ENGAGEMENT ISSUES WITH THE STAPLERS. THE STAFF ATTEMPTED TO RESOLVE THE ISSUE BY SWAPPING TO BACKUP STAPLERS, BUT THE ISSUE PERSISTED. THERE WERE NO COMPLICATIONS DUE TO THE CONVERSION. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2894508 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES