BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21120813 · Received January 9, 2025

    Report

    Report Number
    2955842-2025-00253
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 15, 2024
    Report Date
    December 16, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH A 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 THE ENDOSCOPE HOUSING AND FOUND WITH ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT(S) TO THE CABLE INSULATION AND COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ENDOSCOPE WAS DISASSEMBLED AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND PLACED ON AN INTERNAL TESTER AND FAILED. THE CAMERA MODULE FAILED THE NO IMAGE TEST. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON ISI TECHNICAL SUPPORT ENGINEER (TSE) NOTES, THE ALLEGED ISSUE WAS DUE TO A LOOSELY CONNECTED, IMPROPERLY SEATED, OR DISCONNECTED PART.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE TO THE ROBOTICS COORDINATOR WHO INDICATED THAT HE COULD NOT REPRODUCE THE ISSUE. TWO CASES WERE COMPLETED WITH NO ISSUES. THE ROBOTICS COORDINATOR BELIEVES THIS WAS A USER INDUCED ISSUE. NO SITE VISIT WAS PERFORMED. ISI HAS NOT RECEIVED THE 30-DEGREE ENDOSCOPE FOR EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NON-INTUITIVE MOTION ISSUE. THE SURGICAL STAFF TRIED REPLACING THE ENDOSCOPES AND POWER CYCLING THE SYSTEM, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THE IMAGE WAS INVERTED, AND THE INSTRUMENTS WERE MOVING IN THE OPPOSITE DIRECTION. THE PROCEDURE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417304 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

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