BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18414221 · Received December 28, 2023

    Report

    Report Number
    2955842-2023-21511
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 5, 2023
    Report Date
    December 5, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO REMOVE THE ENDOSCOPE FROM UNIVERSAL SURGICAL MANIPULATOR (USM) 3, PRESS PORT OR INSTRUMENT CLUTCH BUTTON ONCE AND REINSTALL AND ADVANCE THE SCOPE. THE CUSTOMER CONFIRMED THAT THE ACTION RESOLVED THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTED RECOVERABLE FAULT DURING SURGERY. INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE ONSITE LOGS, FOUND ERROR 23003 ON ENDOSCOPE ROTATION. CUSTOMER STATED THE ENDOSCOPE FLIPPED ORIENTATION AS SOON AS FAULT WAS RECOVERED. TSE ASKED CUSTOMER TO REMOVE ENDOSCOPE FROM UNIVERSAL SURGICAL MANIPULATOR (USM)3, PRESS PORT OR INSTRUMENT CLUTCH BUTTON ONCE AND REINSTALL AND ADVANCE SCOPE. CUSTOMER CONFIRMED ISSUE IS RESOLVED. TSE ASKED CUSTOMER TO CHECK SCOPE SHAFT FOR RESISTANCE AT END OF PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530423 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-62 N/A 00886874112212

    Patients

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