BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19608272 · Received June 25, 2024

    Report

    Report Number
    2955842-2024-16212
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS 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 ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE ENDOSCOPE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE TURNED OVER AUTOMATICALLY RESULTING IN THE SUDDEN LOSS OF THE FIELD OF VIEW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STOPPED USING THE ENDOSCOPE WHEN THE ERROR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448229 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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