BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 18280163 · Received December 6, 2023

    Report

    Report Number
    2955842-2023-21008
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 15, 2023
    Report Date
    November 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30-DEGREE ENDOSCOPE PLUS WAS ANALYZED AND PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH AN ENDOSCOPE ADAPTER (AEA) BEARING CONTRIBUTING TO FRICTION. ADDITIONALLY, THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER CALLED IN TO REPORT THAT THEY WERE FACING AN ENDOSCOPE ISSUE MAKING NON-INTUITIVE MOTION. TECHNICAL SUPPORT ENGINEER (TSE) CONNECTED TO THE SYSTEM AND NOTICED THAT THE ENDOSCOPE WAS NOT PROPERLY DETECTED; UP OR DOWN POSITION WAS NOT INDICATED. TSE ASKED CUSTOMER TO RESEAT THE ENDOSCOPE AND THE STERILE ADAPTER. CUSTOMER STATED THAT THE SURGEON DID NOT WANT TO, AND THE SURGERY WOULD END IN 10 MINUTES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128361 DA VINCI ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A

    Patients

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