BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19085395 · Received April 10, 2024

    Report

    Report Number
    2955842-2024-13099
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 15, 2024
    Report Date
    March 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    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 ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE A BINDING/FRICTION ISSUE ON THE CAMERA ADAPTER. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE WAS DIFFICULT TO ROTATE. THE CUSTOMER USED A BACKUP ENDOSCOPE TO CONTINUE WITH THE PROCEDURE. 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 ENDOSCOPE IMAGE WAS INVERTED. THE ENDOSCOPE DID NOT MOVE IN OPPOSITE DIRECTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME DA VINCI SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691118 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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