BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21991295 · Received May 9, 2025

    Report

    Report Number
    2955842-2025-19870
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 29, 2025
    Report Date
    May 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    IZI
    UDI-DI
    00886874122228
    PMA / PMN Number
    K212101
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE ENDOSCOPE INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE FIREFLY WAS ANALYZED AND FOUND TO HAVE SHAFT MECHANICAL DAMAGE. THE DISTAL MAIN TUBE WAS FOUND TO BE BENT OUTWARD. DESPITE THE DAMAGE ON THE DISTAL MAIN TUBE, THE ENDOSCOPE WAS STILL FULLY FUNCTIONAL. ALTHOUGH THE SHAFT MECHANICAL WAS DAMAGED, THE QAP (QUALITY ASSURANCE PROCEDURE) COULD STILL BE PERFORMED ON THE IN-HOUSE SYSTEM. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. STEREO CALIBRATION, ENDOSCOPE FOCUS TEST AND COLOR RECOGNITION WAS PERFORMED AND PASSED. IMAGES WERE CLEAR, DEWARPED AND NOT GRAINY. NO NOISE OR MOTION BLUR WAS SEEN. THE BUTTONS WERE FULLY FUNCTIONAL AND MOVED INTUITIVELY. FIRST AND SECOND EDT TESTING PASSED. REVIEW OF LOGS SHOWED QTY 5 OF ERROR 48221 (COMMUNICATIONS ERROR) AND QTY 1 OF ERROR 48216 (TEMPERATURE SENSOR FAILURE), BOTH WERE NOT REPLICATED IN HOUSE. LEAK TESTS WERE PERFORMED AND PASSED. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE ENDOSCOPE WAS FOUND TO BE CORRODED/CONTAMINATED. THE HOUSING WAS REMOVED AND FOUND CORROSION/CONTAMINATION ON THE INPUT DISK/CABLES.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SP ENDOSCOPE FIREFLY FOR FAILURE ANALYSIS INVESTIGATION. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE THE DISTAL TIP INSPECTED. THE SHAFT MECHANICAL DAMAGE WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SP ENDOSCOPE FIREFLY HAD DISTAL JOINT CRUSHED INWARD. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PATIENT WAS NOT HARMED. THERE WAS NO DELAY IN CASE AND BACKUP WAS AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945515 ENDOWRIST SP CAMERA, 0° IZI INTUITIVE SURGICAL, INC 430077-05 N/A 00886874122228

    Patients

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