BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23228994 · Received October 6, 2025

    Report

    Report Number
    2955842-2025-40414
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 11, 2025
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN INADEQUATE CONNECTION OF ENDOSCOPE TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) OR DISENGAGEMENT OF THE ENDOSCOPE FROM THE USM. THE CUSTOMER CONTINUED TO USE THE ENDOSCOPE TO COMPLETE THE PROCEDURE AND BASED ON REVIEW OF THE LOGS, THE ENDOSCOPE WAS CONTINUED TO BE USED AFTER THE REPORTED EVENT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE 30 DEGREE ENDOSCOPE HAD AN INVERTED SCOPE POSITION WITH NON-INTUITIVE MOVEMENT. THE CUSTOMER RESEATED THE CANNULA, THE INSTRUMENT ARM DRAPE, AND THE 30 DEGREE ENDOSCOPE TO RECOVER INTUITIVE AND COHERENT MOVEMENT. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND ERROR 22020. TSE INFORMED THE CUSTOMER THAT THE INSTALLATION ISSUE WITH THE INSTRUMENT AND THE ACCESSORY CAN LEAD TO THE FAULT AND THE CUSTOMER AGREED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. ENDOSCOPE WAS INSPECTED WITH NO DAMAGE. IT WAS A PARTIAL NEPHRECTOMY. IMAGE WAS INVERTED. ENDOSCOPE DID NOT MOVE FREELY WITH UNCONTROLLED MOTION. EVENT DID NOT INVOLVE A REVERSED CONTROL ON THE SYSTEM. IT WAS A 30-DEGREE ENDOSCOPE IN DOWN ORIENTATION. SURGEON CONFIRMED DESIRED ORIENTATION. NO INDICATION OF THE IMAGE ORIENTATION WAS PROVIDED. ENDOSCOPE AND ADAPTER/BASE WERE ATTACHED BUT MAYBE NOT VERY WELL ENGAGED, THAT MIGHT HAVE BEEN THE ISSUE. NO DAMAGE ON THE ENDOSCOPE. ENDOSCOPE WAS REMOVED, UN-DOCKED AND DOCKED AGAIN. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487343 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A

    Patients

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