BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18772067 · Received February 23, 2024

    Report

    Report Number
    2955842-2024-11701
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 31, 2024
    Report Date
    January 31, 2024
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY, AND NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 30-DEGREE PLUS ENDOSCOPE FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SYSTEM HAD AN ENGAGEMENT ERROR WHILE REMOVING THE 30-DEGREE ENDOSCOPE. THE ENDOSCOPE HOUSING COULD NOT BE ROTATED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE IMAGE WAS INVERTED ALTHOUGH THE ENDOSCOPE DID NOT ROTATE. THE VISION ORIENTATION DID NOT CHANGE ON ITS OWN. THE ENDOSCOPE WAS CONTROLLED VIA TOUCHPAD. THE ENDOSCOPE DID NOT MOVE SMOOTHLY, AND THE ENDOSCOPE BASE WAS DIFFICULT TO ROTATE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112738 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A

    Patients

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