BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 8968417 · Received September 6, 2019

    Report

    Report Number
    2955842-2019-10687
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 9, 2019
    Report Date
    August 12, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 8MM TIP COVER ACCESSORY WAS RETURNED TO THE ISI. THE FAILURE INVESTIGATION WAS COMPLETED ON THE RETURNED TIP COVER ACCESSORY AND NO FAILURES WERE DETECTED ON THE RETURNED UNIT. THE PRODUCT WAS RETURNED IN ITS ORIGINAL PACKAGING. FAILURE ANALYSIS CONFIRMED THAT NO DAMAGE WAS FOUND. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE THE 8MM TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE TIP COVER ACCESSORY WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM TIP COVER ACCESSORY FELL INTO THE PATIENT. IT WAS NOTED THAT THE TIP COVER WAS RETRIEVED AND THAT THE CASE WAS COMPLETED WITH ANOTHER TIP COVER. ON 08/28/2019, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATION THEATER MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON RETRIEVED THE 8MM TIP COVER ACCESSORY DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY AND NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT DID NOT RETURN WITH ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762930 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 M10190219

    Patients

    Seq Age Sex Outcome Treatment
    1