BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20860624 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22826
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT ISSUED THE RETURN OF THE ENDOSCOPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS HAD THE IMAGE BEING UPSIDE DOWN. THE REPORTED EVENT WAS RESOLVED ONCE THE CUSTOMER REPLACED THE ENDOSCOPE. THE CUSTOMER WAS ADVISED TO MARK THE ENDOSCOPE. IF THE REPORTED EVENT IS TO REOCCUR TO CLEAR THE GTE MEMORY ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND THEN REINSTALL THE ENDOSCOPE WITH THE ORIENTATION THE CUSTOMER WANTS TO USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NEXT TIME THEY USED THE 30-DEGREE LENS, IT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290014 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES