BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22049732 · Received May 20, 2025

    Report

    Report Number
    2955842-2025-20993
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 24, 2025
    Report Date
    April 24, 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
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE 30 DEGREE ENDOSCOPE BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE HAIRLINE CRACK(S) ON THE BUTTON PACK ASSEMBLY. ADDITIONAL OBSERVATIONS : THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE DID NOT ROTATE PROPERLY AND UPON INSPECTION, THE ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING WAS OBSERVED TO BE CONTRIBUTING TO THE FRICTION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30 DEG. ENDOSCOPE PLUS WAS ANALYZED. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE TO THE BUTTON PACK ASSEMBLY. VISUAL INSPECTION CONFIRMED HAIRLINE CRACK(S) ON ILLUMINATION OF THE BUTTON PACK ASSEMBLY. THE ROOT CAUSE OF CAMERA BUTTON PACK. ADDITIONALLY, 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. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH 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 REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO MECHANICAL DAMAGE DURING USE OR IMPROPER HANDLING, WHICH MAY INCLUDE ACCIDENTAL DROPS OF THE ENDOSCOPE. IN SOME CASES, EXTENSIVE CRACKING LEADING TO THE BUTTON PACK BREAKING OFF CAN OCCUR, WHICH IS LIKELY CAUSED BY IMPROPER CLEANING DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30 DEGREE ENDOSCOPE WAS FOUND BROKEN. AT THIS TIME, IT IS UNKNOWN IF THERE WAS FRAGMENT FALLING INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAVINCI COORDINATOR WAS NOT MADE AWARE OF THIS SITUATION OR KNOW ANY DETAILS.

    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
    2143230 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.