BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20503276 · Received October 22, 2024

    Report

    Report Number
    2955842-2024-20763
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30 DEGREE ENDOSCOPE WAS ANALYZED AND THE REPORTED COMPLAINT WAS CONFIRMED AND REPLICATED. THE ENDOSCOPE WAS PLACED THROUGH A FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. ADDITIONALLY, THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT(S) TO THE CABLE INSULATION. THE ENDOSCOPE WAS ALSO FOUND WITH COSMETIC DAMAGE. THE CABLE-INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE MOVED 90 DEGREES AFTER IT WAS INSTALLED. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) EXPLAINED THAT THE ISSUE COULD BE DUE TO GUIDE TOOL CHANGE (GTC) FUNCTION. LATER THAT DAY, THE CUSTOMER CALLED BACK AND CONFIRMED THAT THE ENDOSCOPE ROTATION DID NOT WORK PROPERLY. AFTER THE CUSTOMER REMOVED THE ENDOSCOPE AND ROTATED IT MANUALLY, THE ENDOSCOPE ROTATION WAS HARDER THAN NORMAL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS NOT INVERTED. THE ENDOSCOPE ROTATION STOPPED MIDWAY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029389 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES