BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17715764 · Received September 8, 2023

    Report

    Report Number
    2955842-2023-18342
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 10, 2023
    Report Date
    August 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE SCOPE WAS FOUND TO HAVE FRICTION ISSUE TO THE ADVANCED ENDOSCOPE ADAPTER BEARINGS. THE ENDOSCOPE WAS PLACED ON AN IN-HOUSE DIAGNOSTIC TESTER OR EQUIVALENT AND FOUND WITH LOCAL BUTTON CONTROLS NOT WORKING PROPERLY. THE ENDOSCOPE FAILED THE BUTTON FUNCTIONALITY TEST DUE TO THE ENTER BUTTON NOT WORKING WHEN ACTIVATED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTIES WHEN CHANGING THE SCOPES FROM UP TO DOWN AND VICE VERSA. THE IMAGE GOT MIRRORED. A BACKUP ENDOSCOPE WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE ISSUE OCCURRED DURING THE PROCEDURE, AFTER PORTS WERE PLACED. A BACKUP ENDOSCOPE WAS USED TO CONTINUE AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242929 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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