BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 14876504 · Received June 30, 2022

    Report

    Report Number
    2955842-2022-12647
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Report Date
    October 27, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    10886874112547
    PMA / PMN Number
    K133845
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE REPORTED SAFETY CONCERN ¿ABOUT THE STOPCOCK SWITCH ON THE XI CANNULA SEALS BEING SO LOOSE THEY RANDOMLY WILL MOVE, EITHER ALLOWING GAS TO ESCAPE OR SHUTTING OFF THE INSUFFLATION TO THE ABDOMEN¿ REMAINS UNKNOWN. THERE IS NO RMA ASSOCIATED WITH THIS COMPLAINT AND THEREFORE, THERE ARE NO ISI PRODUCTS EXPECTED TO RETURN FOR EVALUATION. A COMPLAINT INVESTIGATION COULD NOT BE PERFORMED SINCE THE SITE AND PRODUCT INFORMATION COULD NOT BE COLLECTED AT THIS TIME. ALSO, A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE IT IS NOT RELEVANT TO THE ALLEGED COMPLAINT. NO IMAGE OR VIDEO WAS PROVIDED TO ISI FOR REVIEW. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-EVALUATED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE STOPCOCK SWITCH ON THE XI CANNULA SEALS BEING LOOSE WOULD RANDOMLY ALLOW FOR GAS TO ESCAPE OR RESULT IN A SHUTTING OFF OF THE INSUFFLATION TO THE ABDOMEN. WHILE THERE WAS NO REPORTED HARM OR INJURY TO A PATIENT, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION, AS THE OBSERVED FAILURE MODE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN FIELDS E1, E3, AND G2 ADDITIONAL INFORMATION CAN BE FOUND IN FIELD H10: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE ISI REPRESENTATIVE THAT INITIALLY REPORTED THE ISSUE: THE ISI REPRESENTATIVE WAS PRESENT FOR A PROCEDURE WHEN THE FIRST ASSIST FOR THE PROCEDURE NOTED THAT THE CANNULA SEAL¿S GRAY SWITCH WAS LOOSE AND WOULD SLIP BACK AND FORTH RESULTING IN IT INADVERTENTLY OPENING. THE FIRST ASSIST NOTED THAT THEY HAD SEEN THE ISSUE OCCUR DURING OTHER PROCEDURES ACROSS MULTIPLE HOSPITALS IN THE AREA AS THE FIRST ASSIST WOULD REGULARLY WORK AT MULTIPLE DIFFERENT HOSPITALS WITH MULTIPLE DIFFERENT SURGEONS. THE FIRST ASSIST INDICATED THAT THEY WERE ABLE TO QUICKLY SWITCH THE SEAL BACK TO ITS INTENDED POSITION AND CONTINUE WITH THE PROCEDURE WHENEVER THE ISSUE OCCURRED. THE ISI REPRESENTATIVE DID NOT RECALL ANY INSTANCE OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME OCCURRING AND INDICATED THAT HE DOES NOT BELIEVE THERE WERE ANY ADVERSE EVENTS OR PROCEDURE CONVERSIONS AS A RESULT OF THE REPORTED ISSUE. THE ISI REPRESENTATIVE ALSO INDICATED THAT HE DOES NOT RECALL ANY INSTANCE OF PATIENT HARM EVER BEING REPORTED TO HIM AS A RESULT OF THE REPORTED PROBLEM. THE ISI REPRESENTATIVE INDICATED THAT HE DID NOT RECALL THE SPECIFIC PROCEDURE TYPE OR THE NAMES OF THE SURGEON AND/OR FIRST ASSIST FOR THE EVENT WHERE THE ISSUE WAS INITIALLY REPORTED TO HIM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI) COMPLAINTS FROM SURGEONS/STAFF AT MORE THAN 1 HOSPITAL ABOUT THE STOPCOCK SWITCH ON THE XI CANNULA SEALS BEING SO LOOSE THEY RANDOMLY WILL MOVE, EITHER ALLOWING GAS TO ESCAPE OR SHUTTING OFF THE INSUFFLATION TO THE ABDOMEN. UPON INSPECTION BY THE CUSTOMER, THE XI CANNULA SEALS WERE NOTED TO BE VERY LOOSE, AND THE SMALLEST MOVEMENT BY THE INSTRUMENT ARM WILL CAUSE THIS TO HAPPEN. REPORTEDLY, THIS HAS OCCURRED WHILE THE SURGEON IS WORKING, THEN THE PATIENT¿S ABDOMEN QUICKLY LOSES GAS WITH INSTRUMENTS IN. IT IS UNKNOWN WHETHER ANY SERIOUS INJURY TO THE PATIENT HAS OCCURRED DUE TO ABDOMEN QUICKLY LOSING GAS DURING THE PROCEDURES.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058998 NONE CANNULA SEAL GCJ INTUITIVE SURGICAL, INC 470361-08 L10200228 10886874112547

    Patients

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