BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17798044 · Received September 22, 2023

    Report

    Report Number
    2955842-2023-18653
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE TESTED THE TWO ENDOSCOPES (10028914 &10017969) THAT WERE USED DURING THIS REPORTED PROCEDURE. THE FSE COULD NOT REPLICATE THE CUSTOMER REPORTED ISSUE ON UNIVERSAL SURGICAL MANIPULATORS (USMS) 2, 3 AND 4. THE FSE ALSO NOTED THAT THE ISSUE WAS RESOLVED ON THE PHONE WITH ISI TECHNICAL SUPPORT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE USER COULD NOT GET AN ENDOSCOPE THAT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3 TO ROTATE FROM UP TO DOWN AND VICE VERSA. THE SURGICAL STAFF HAD ATTEMPTED TO RESEAT THE STERILE ADAPTER AND ENDOSCOPE, BUT THE ISSUE WAS NOT RESOLVED. THE SURGICAL STAFF THEN TRIED ANOTHER ENDOSCOPE AND POWER CYCLED THE SYSTEM, BUT THE ISSUE PERSISTED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERROR CODES POINTING TO BLUE FIBER CABLES. THE TSE SUGGESTED TO CHECK THE BLUE FIBER CABLE CONNECTIONS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229201 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A

    Patients

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