BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19131130 · Received April 18, 2024

    Report

    Report Number
    2955842-2024-13568
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 26, 2024
    Report Date
    March 26, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS BEEN RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION WAS PERFORMED BY THE FAILURE ANALYSIS TEAM. THE ENDOSCOPE WAS TESTED AND PLACED ON A CAMERA ATTENUATION TESTER OR EQUIVALENT TO MEASURE TRANSMITTANCE BUT FAILED FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TRANSMITTANCE DUE TO THE MEASURED OUTPUT POWER NOT MEETING SPECIFICATION LIMITS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30 DEGREES ENDOSCOPE PLUS WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED BUT NOT REPLICATED. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE DIFFERENCES OBSERVED IN THE POSITION OF THE 30-DEGREE ENDOSCOPE PLUS AND THE IMAGE DISPLAYED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS INVERTED. THE ENDOSCOPE DID NOT FREELY MOVE WITH UNCONTROLLED MOTION. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS. THE ENDOSCOPE WAS INSTALLED IN THE LOWER ALIGNMENT. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED AND THERE WAS AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA USER INTERFACE. THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE WERE STILL ENGAGED/IN-SYNCH/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE SUCH AS MISSING SCREW(S) OR COMPONENT. A SECOND ENDOSCOPE WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423222 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.