BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14504838 · Received May 26, 2022

    Report

    Report Number
    2955842-2022-11798
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 27, 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
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE ISSUE WAS CONFIRMED DURING INSPECTION OF THE SYSTEM. FSE FOUND THE FIBER CABLE PORT LYING INSIDE OF THE PATIENT SIDE CART (PSC). ADDITIONALLY, THE RETAINING NUT AND DUST CAP OF THE PSC WERE ALSO FOUND DAMAGED. FSE TESTED THE PSC USING A NEW FIBER CABLE; HOWEVER, THE GBIT COMMUNICATION STATUS WAS SLIGHTLY LOWER THAN AVERAGE SPEEDS. THE PSC FIBER CABLE PORT WAS REPLACED AND VERIFIED THAT PORT SPEED HAD INCREASED. A NEW DUST CAP WAS INSTALLED TO COMPLETE REPAIR. PSC WAS RESTORED TO FULL SPECIFICATION. THE SYSTEM WAS RETESTED, OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. ISI RECEIVED THE FIBER OPTIC CABLE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. REVIEW OF THE REMOTE FE LOGS CONFIRMED SEVERAL ERROR FAULT ON THE REPORTED EVENT DATE RELATED TO A COMMUNICATION FAULT CONFIRMING THE CUSTOMER REPORTED ISSUE. FAILURE ANALYSIS (FA) INVESTIGATION OF THE RETURNED CABLE WITH THE TEST SYSTEM FOUND NO ISSUE. THE TEST SYSTEM OPERATED AS EXPECTED AND FA WAS UNABLE REPRODUCE THE REPORTED COMPLAINT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THERE WAS NO IMAGE OR VIDEO CLIP SUBMITTED FOR REVIEW. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM (B)(4) MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI FSE'S INVESTIGATION. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO AN ISSUE WITH THE PATIENT SIDE CART. 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE BLUE FIBER CABLE AND BLUE FIBER CABLE PORT ON THE PATIENT SIDE CART (PSC) WAS DAMAGED AND PULLED APART WHILE DOCKING THE PSC. THE SURGEON ELECTED TO COMPLETE THE PROCEDURE THROUGH TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814710 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

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