BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8428558 · Received March 18, 2019

    Report

    Report Number
    2955842-2019-10194
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 19, 2019
    Report Date
    February 19, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) WILL NOT RECEIVE THE REPORTED FRAGMENT FOR FAILURE ANALYSIS INVESTIGATIONS BECAUSE IT HAS BEEN DISCARDED BY OR STAFF. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT WAS IDENTIFIED WITHIN A PATIENT. WHILE OR STAFF COULD NOT DETERMINE THE ORIGIN OF THE FRAGMENT, THEY ALSO INDICATED THAT THE FRAGMENT COULD SHARE CHARACTERISTICS WITH THE INSULATION OF BIPOLAR INSTRUMENTS. ALTHOUGH THE FRAGMENT WAS RETRIEVED WITHOUT PATIENT HARM, ADVERSE OUTCOME OR INJURY, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL BLACK PIECE OF PLASTIC WAS FOUND INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT. THE DA VINCI SURGICAL SYSTEM AND MULTIPLE INSTRUMENTS WERE IN USE. AFTER FRAGMENT REMOVAL, ALL INSTRUMENTS WERE INSPECTED FOR DAMAGE, SCRATCHES, OR DEFECTS. NO DAMAGE OR ISSUES WERE FOUND AND THE INSTRUMENTS WERE REINSTALLED ON THE SYSTEM TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENTIRE FRAGMENT WAS RETRIEVED AND NO POSTOPERATIVE TESTS WERE NEEDED. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) AND OPERATING ROOM (OR) STAFF INSPECTED THE INSTRUMENTS IN USE AND COULD NOT DETERMINE THE ORIGIN OF THE FRAGMENT. OR STAFF WERE UNCERTAIN WHEN OR HOW THE FRAGMENT ENTERED THE PATIENT, BUT INDICATED THAT THE FRAGMENT SHARED CHARACTERISTICS WITH THE INSULATION OF BIPOLAR INSTRUMENTS. OR STAFF AND THE INITIAL REPORTER ESTIMATED THAT THE FRAGMENT WAS APPROXIMATELY TWO CENTIMETERS IN LENGTH. THE INITIAL REPORTER AND OR STAFF CONFIRMED THAT ALL INSTRUMENTS FUNCTIONED AS EXPECTED. THE INITIAL REPORTER CONFIRMED THAT ALL INSTRUMENTS WERE INSPECTED PRIOR TO USE. IT IS UNKNOWN IF THE CANNULAS WERE INSPECTED PRIOR TO USE. THE INITIAL REPORTER INDICATED THAT THE FRAGMENT WAS DISCARDED BY OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222612 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES