BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 14533454 · Received May 28, 2022

    Report

    Report Number
    2955842-2022-11859
    Event Type
    Malfunction
    Date Received
    May 28, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 27, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND CONFIRMED THE CUSTOMER WAS ABLE TO MOVE THE ENDOSCOPE TO USM 1 TO USE IT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. AN RFE REPORT REVIEW WAS PERFORMED. LOGS CONFIRMED THAT THE PARTIAL NEPHRECTOMY PROCEDURE WAS PERFORMED BY SURGEON (B)(6) ON (B)(6) 2022 ON SYSTEM (B)(4) WITH THE 30 DEGREE ENDOSCOPE (S/N (B)(4)). BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO UNKNOWN REASONS. 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE SITE HAD A POSITIONING ISSUE WITH THE ENDOSCOPE ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND 2. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS AND DID NOT FIND ANY RELEVANT ERRORS. THE TSE EXPLAINED THE ISSUE WAS MOST LIKELY DUE TO USM POSITIONING. THE PROCEDURE WAS CONVERTED TO AN UNSPECIFIED PROCEDURE TYPE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 28-APR-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS UNCOMFORTABLE. THE PROCEDURE WAS CONVERTED, BUT NOT BECAUSE OF THE ENDOSCOPE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204018 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-38 N/A 00886874115404

    Patients

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