BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22118292 · Received May 30, 2025

    Report

    Report Number
    2955842-2025-20961
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 9, 2025
    Report Date
    May 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 0-DEGREE ENDOSCOPE PLUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, 0-DEGREE ENDOSCOPE PLUS MOVED BACKWARD. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). BEFORE THE PHONE CALL, SITE USED TWO DIFFERENT ENDOSCOPES WITH THE SAME ISSUE. TSE COULD NOT FIND ANY RELATED ERRORS IN THE LOGS. TSE HAD SITE ORIENT THE ENDOSCOPE TO THE DESIRED LOCATION AND CANCEL GUIDE TOOL CHANGE (GTC), BUT THE ISSUE PERSISTED. AFTER, TSE HAD SITE RESEAT STERILE ADAPTER (SA) ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21490 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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