BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17015885 · Received May 28, 2023

    Report

    Report Number
    2955842-2023-15004
    Event Type
    Malfunction
    Date Received
    May 28, 2023
    Date of Event
    May 18, 2022
    Report Date
    June 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 30-DEGREE ENDOSCOPE ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE REPORTED ISSUE IS DUE TO ATTACHED ENDOSCOPE ADAPTER (AEA) DAMAGED OR FRICTION ISSUE WITH DISCOLORATION OF IC HOUSING. THE ENDOSCOPE FAILED AT CAT FOR ATTENUATION. THE CABLE WAS PASSED, AND PAYLOAD FAILED LIGHT LEAKAGE TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 30-DEGREE ENDOSCOPE HAD AN INVERTED IMAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848976 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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