BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20330428 · Received September 29, 2024

    Report

    Report Number
    2955842-2024-19885
    Event Type
    Malfunction
    Date Received
    September 29, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 4, 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 FA CONFIRMED AND REPLICATED THE CUSTOMER-REPORTED COMPLAINT. 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/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. ADDITIONALLY, THERE WAS FOREIGN LABELING IN THE CABLE CONNECTOR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, 30 DEGREE ENDOSCOPE IMAGE FLIPPED UPSIDE DOWN. THE CUSTOMER REINSTALLED THE ENDOSCOPE TO RESOLVE THE ISSUE. THE CUSTOMER USED THE SAME ENDOSCOPE TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE CUSTOMER FOUND THAT 30 DEGREE ENDOSCOPE BASE HAD ABNORMAL NOISE, AND THERE WAS RESISTANCE WHEN TURNING THE ENDOSCOPE BY HAND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603399 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