BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21193262 · Received January 20, 2025

    Report

    Report Number
    2955842-2025-00375
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 8, 2025
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE WAS ANALYZED AND FOUND A CAMERA INSTRUMENT ADAPTER DEFECT CHARACTERIZED BY BINDING AND FRICTION DURING TESTING. A FRICTION TEST USING A SCREENING AIDE CONFIRMED IMPROPER ROTATION AND AUDIBLE NOISE, LEADING TO THE REMOVAL AND INSPECTION OF THE ADAPTER, WHERE THE SHAFT BEARING WAS FOUND TO BE THE CONTRIBUTING FACTOR. ADDITIONALLY, MECHANICAL DAMAGE WAS OBSERVED ON THE SCOPE¿S DISTAL TIP, ALONG WITH COSMETIC DAMAGE TO THE ENDOSCOPE. INSPECTION OF THE CABLE INTEGRATED CONNECTOR REVEALED DISCOLORATION, AND FURTHER EVALUATION FOUND A MINOR CUT IN THE CABLE INSULATION NEAR ZONE A, CLOSE TO THE INTEGRATED CONNECTOR. A 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 FOR BINDING AND FRICTION IN ENDOSCOPE IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.

    Additional Manufacturer Narrative · 0

    AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. THE REOCCURRENCE OF THE ALLEGED FAILURE MODE WOULD NOT CAUSE NOR CONTRIBUTE TO AN ADVERSE EVENT OR SERIOUS INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS INVERTED. THE EVENT DID NOT INVOLVE REVERSED CONTROL ON SYSTEM ARMS. THERE WAS NO MATERIAL MISSING/ DETACHED FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. THE ISSUE WAS NOT RELATED TO A FUNCTIONAL FAILURE OR PHYSICAL DAMAGE. THE ISSUE DID INCLUDE A VISION ISSUE AS IT WAS UNABLE TO FOCUS IMAGE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440699 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