BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VICNI

    MDR report key: 19915094 · Received August 6, 2024

    Report

    Report Number
    2955842-2024-17860
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE MCS TIP COVER ACCESSORY WAS DISPOSED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIES COMPLAINTS RELATED TO THIS EVENT. THE REPORT UNDER PATIENT IDENTIFIER (B)(4) DOCUMENTS THE OCCURRENCE OF THE EVENT ON UNKNOWN DATE OF A FRAGMENT FALLING INTO PATIENT, WHILE THE REPORTS UNDER PATIENT IDENTIFIERS (B)(4) DOCUMENT OTHER INSTANCES OF THE MCS TIP COVER FALLING INTO THE TROCAR DURING PROCEDURES PERFORMED ON UNKNOWN DATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE CUSTOMER OBSERVED THAT IN THREE CASES, MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS SLOWLY SLIDING DOWN FROM THE MCS INSTRUMENT WHERE THE ORANGE LINE STARTED TO BE UNCOVERED. AT THAT POINT USER IMMEDIATELY STOPPED USING THE MCS INSTRUMENT AND RETRIEVED THEM FROM PATIENT`S ABDOMEN. DURING ONE CASE, THE MCS TIP COVER ACCESSORY DROPPED BACK TO PATIENT ABDOMEN IN ONE CASE. IN THE TWO OTHER CASES THE MCS TIP COVER ACCESSORY GOT STUCK IN 8 MM ROBOTIC TROCAR. IN ALL THREE CASES MCS TIP COVERS WERE SUCCESSFULLY REMOVED BY LAPAROSCOPIC INSTRUMENT. THE EXACT EVENT DATE IS UNKNOWN, THESE INCIDENTS HAPPENED WITHIN THE LAST TWO MONTHS. THE PROCEDURE WAS COMPLETED. ON (B)(6) 2024, INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THEY DO NOT HAVE EXACT DATE OF EVENT. THE INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, EVERY SINGLE INSTRUMENT HAS BEEN INSPECTED PRIOR TO USE AND NO DAMAGE IN THAT TIME OTHERWISE INSTRUMENT WOULD NOT BE USED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BY THE ORDINARY LAPAROSCOPIC INSTRUMENT THROUGH THE 12MM TROCAR WITH REDUCER. DISSECTING THE TISSUE WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON WAS NOT SURE WHAT COULD CAUSE THE ACCESSORY TO SLIP OFF OR BREAK. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE APPROXIMATELY 3-4 HOURS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY HAS BEEN PROPERLY INSTALLED PRIOR THE SURGERY WITH INSTALLATION TOOLS AND NO ORANGE PART OF SCISSORS WAS VISIBLE. LUBRICANT HAS NOT BEEN USED TO INSTALL THE COVER. ALSO, THE COVER WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. A REDUCER WAS USED. REPORTER FURTHER CONFIRMED THAT REMOVING THE INSTRUMENT WAS NOT DIFFICULT FROM THE TROCAR HOWEVER IN 2 CASES COVER REMAIN IN THE TROCAR AND IN ONE CASE COVER DROPPED BACK TO PATIENT ABDOMEN. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED BY ROBOT. THE NEW TIP COVER HAS BEEN INSTALLED. REPORTER CONFIRMED THAT THERE WAS NO HARM TO PATIENT. THE ISSUE DID NOT CAUSE ANY DELAY THE PROCEDURE. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION, AS IT HAS BEEN DISPOSED TO THE CLINICAL WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675550 DA VICNI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180 N/A

    Patients

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